The GANNET53 project is coordinated by Nicole Concin at the Medizinische Universität Innsbruck (Innsbruck Medical University; IMU; https://www.i-med.ac.at/mypoint/). Four departments/ units within the legal entity IMU have a distinct and central role in the GANNET53 project.

a) Trial centre of the Austrian Gynaecological Oncology Trial Group (Austrian-AGO)

Description:

The trial centre of the Austrian-AGO (http://ago-austria.at/) is a unit and thereby part of the IMU. The Austrian-AGO trial centre is the legal sponsor and the Austrian-AGO is the lead-clincal trial group in the GANNET53 trial. The Austrian-AGO was founded in 2002 to organise all Austrian gynaecological oncological trials. The Austrian-AGO has since then coordinated, managed and supported more than 30 multicentre, multinational clinical trials according to ICH-GCP guidelines. For several academic studies the Austrian-AGO also served as legal sponsor. Austrian-AGO is member of the Gynaecologic Cancer Intergroup (GCIG) and the European Network of Gynaecological Oncological Trial Groups (ENGOT), which is supported by and part of the European Society of Gynaecologic Oncology (ESGO).

Staff members:

Christian Marth, MD, PhD, President of the Austrian-AGO and of ENGOT: Principal Investigator of >40 clinical Phase II and III trials; Council member of the ESGO and member of the board of directors of the Gynaecologic Cancer InterGroup (GCIG); Since 6 years Chair of the ovarian cancer committee of the GCIG; Reviewer of several scientific journals; Lead Investigator/Austrian-AGO lead-trial group for multinational, multicentre Trinova 2 study; Regina Berger, PhD, Head of the Austrian-AGO trial centre: PhD in molecular biology; Post-Doc/Scientist in several preclinical studies; Ulrike Pachmann, Msc, study coordinator; Sophia Hold, MA (deputy study coordinator), Sarah Dobner (study nurse).

b) Clinical Trial Centre (Koordinierungszentrum für Klinische Studien, KKS)

Description:

The IMU clinical trial centre (KKS) will perform the monitoring at all patient-recruiting sites in Austria, Germany, France and Belgium. The organisational unit “Clinical Trial Centre” at IMU was founded in October 2006 (http://kks.i-med.ac.at/). Its core competence is to support researchers at IMU in planning, performing and evaluating clinical trials through consultancy and/or direct project contributions. The clinical trial centre offers expert training on all aspects of clinical trials for IMU staff involved in clinical trials at all levels. The IMU clinical trail centre has profound expertise in regulatory framework conditions, national and international legal regulations related to clinical trials, compilation of clinical trial applications (ie protocol definition, definition of ICH key documents), management of clinical trial approval procedures (Ethics Committees and Competent Authorities), monitoring of clinical trials (start-to-end: site initiations, periodic monitoring, site close-outs), project management of clinical trials, management of contractual aspects of clinical trials, medical writing i.e. clinical trial reporting and management of trial master files. The IMU clinical trial centre provides appropriate facilities and trained professionals for management of clinical trials.

Staff members:

Sabine Embacher-Aichhorn, MA, Head of the IMU clinical trial centre. Permanent member of the Competence Mall Initiative of the Austrian Federal Ministry of Health and member of the Austrian Childrens' Research Network (Okids); Martina Mitrovic, MA, Clinical Research Associate; Andreas Kaiser, PhD, Clinical Research Associate; Katharina Stempfl-Al-Jazrawi, PhD, Clinical Research Associate / Data Manager, and Valerie Borek, translator.

c) Department of Obstetrics and Gynaecology

Description:

The Department of Obstetrics and Gynaecology (https://www.i-med.ac.at/patienten/dept_frauenheilkunde.html) will enrol patients and participate in integrated laboratory-based research. IMU is dedicated to patient care, research and education. This comprehensive centre has recently been established with a strong collaboration between the various different disciplines. The Department of Obstetrics and Gynaecology is a large tertiary centre in gynaecologic oncology with more than 500 gynaecologic cancer patients per year. Translational research is facilitated by excellent laboratory facilities with ca. 500 m2 laboratory area. Since 1985 a tissue and serum bank has been built with tissue samples from more than 5,000 cancer patients and about 250,000 serum samples. The Department participates and organises ovarian cancer trials from phase I to phase III with the help of the Austrian-AGO trial centre. The Department of Obstetrics and Gynaecology is publishing more than 40 papers per year in peer-reviewed journals. The Department of Obstetrics and Gynaecology has been involved in the Oncotyrol Project which is a centre of excellence founded with € 28 Mio endowment. It previously also participated in the EU FP6 OVCAD project and is currently involved in many ovarian cancer trials within the European Network of Gynaecological Oncological Trial Groups (ENGOT), Gynaecologic Cancer InterGroup (GCIG), Austrian-AGO and in industry trials in ovarian cancer.

Staff members:

Christian Marth, MD, PhD, is the past-chair of the Austrian Association of Obstetrics and Gynaecology, president of the Austrian-AGO and of ENGOT, council member of the European Society of Gynaecological Oncology (ESGO), and chair of the Ovarian Committee of the Gynaecological Cancer InterGroup (GCIG). He is author of more than 300 original full papers in peer reviewed journals and member of the editorial board of the International Journal of Gynaecological Cancer and serves as a reviewer of numerous medical journals. Alain G. Zeimet, MD, PhD, is the past-president of the Austrian-AGO and leads the gynaecologic oncology group at the Department of Obstetrics and Gynaecology. Nicole Concin, MD, is Professor of Experimental Gynaecology and the coordinator of the GANNET53 project. She is a renowned physician-scientist in p53 translational research in ovarian cancer. Her research group focuses on the clinical relevance of p53 family members (p53/p73 and isoforms) in ovarian cancer and continuously publishes on this topic in high-ranked peer-reviewed journals since 10 years. She is a member of the scientific board of the Austrian-AGO and of the Tumorbank Ovarian Cancer Network (TOC). Katarzyna Koziel, PhD, is a junior postdoc in Nicole Concin`s group. She graduated in molecular biology and oncology. She is trained in the examination of signaling pathways and their deregulation, which can contribute to tumourigenesis. Chiona Gehmacher, Mag, is a GANNET53 project assistant.

d) Department of Medical Statistics, Informatics and Health Economics

Description:

The Department of Medical Statistics, Informatics and Health Economics (https://www.i-med.ac.at/msig/) provides the trial statistician. This department supports all oncologic research activities of the theoretical and clinical institutes. Among others, there is intensive cooperation with the Department of Obstetrics and Gynaecology with a main focus on oncology. p53-based research has been jointly performed over the last 10 years. Main tasks of the Department are statistical consulting regarding the design and analysis of clinical trials. Other services such as data capturing with electronic Case Report Forms (e-CRFs), data management and randomisation are provided as well. The Department employs a total of five highly experienced biostatisticians. In addition, the department has a research focus in the field of cancer epidemiology. The Metabolic Syndrome and Cancer project (Me-Can), in which the Department has a leading role, has produced more than 20 peer-reviewed publications in the last three years. In total, the Department publishes more than 50 scientific papers per year in peer-reviewed journals, mostly in the field of clinical studies.

Staff members:

Hanno Ulmer, PhD, is the director of the Department and will personally be responsible for all statistical issues of the GANNETp53 trial. He is currently the president of the Austro-Swiss Region of the International Biometrical Society and has 20 years of experience in clinical research with more than 350 published articles (h-index 40). He has been the responsible statistician in more than 200 clinical studies, many of which in the field of oncology.

Description:

The University Hospital Leuven is dedicated to research, patient care and education, making it one of the top-Oncology is a tertiary centre treating more than 120 new ovarian cancer patients per year. In addition, about 100 other ovarian cancer patients per year are treated at the time of relapse. A large tumour bank has been assembled over the past 15 years with tissue samples from >2,500 ovarian tumours. The Department currently participates in more than 25 phase I-II or phase III trials in ovarian cancer, involving many new molecular targeted drugs. At the Integrated Laboratory of Experimental Gynaecological Oncology, 3 university professors, 2 post docs and 13 PhD students are currently performing translational research on gynaecological cancers. The division of Gynaecological Cancer research is publishing more than 50 papers per year in peer-reviewed journals. Genetic profiling of ovarian tumours is performed in collaboration with the Vesalius Research Centre, experienced in performing large-scale genetic studies.

The University of Leuven has been involved in the EU FP6 OVCAD project and is involved in the EU FP7 OCTIPS project. Currently the Department is involved in many ovarian cancer trials within the EORTC-Gynaecological Cancer Group, ENGOT (European Network of Gynaecological Trial groups and BGOG (Belgian Gynaecological Oncology Group), as well as in industry trials in ovarian cancer.

Staff members:

Ignace Vergote, MD, PhD, is the Chair of the Protocol Committee of the European Organisation for Research and Treatment of Cancer - Gynaecological Cancer Group (EORTC-GCG), the Past-Chairman of the European Network of Gynaecological Oncological Trial groups (ENGOT), the Chairman of the Leuven Cancer Institute, and is Past-President of the European Society of Gynaecological Oncology (ESGO) and the International Gynaecologic Cancer Society (IGCS). He has authored more than 590 original full papers in peer-reviewed journals, 50 book chapters, and edited several books on Gynaecological Oncology. He is also the Editor of the European Journal of Cancer – Gynaecological Cancer and member of the Editorial Board of numerous medical journals such as the Journal of Clinical Oncology, Gynaecologic Oncology and the Int. J. Gynaecologic Cancer. Sandrina Lambrechts, MD, Evelyn Despierre, MD, and Els Van Nieuwenhuysen, MD, are physicians performing a fellowship in Gynaecologic Oncology. They are also PhD candidates performing translational research on genetic alterations in ovarian cancer.

Three Departments within the legal entity Charité have distinct and important roles in GANNET53 trial:

a) Charité Department of Gynaecology – European Competence Center for Ovarian Cancer – Clinical Trial Unit

Description:

It has a leading position in the treatment and management of patients with ovarian cancer in Germany. Yearly we perform more than 240 multivisceral surgeries due to this disease and about 300 new ovarian cancer patients are treated each year. Since January 2008, our department is a European Competence Centre for ovarian cancer, taking part in many Phase I to Phase III clinical trials for gynaecological malignancies and ovarian cancer in particular. About 180 patients are enrolled yearly in clinical trials. Our institution is strongly linked to the major national and international trial groups (e.g. the NOGGO study centre is established in our Department, AGO study group; ENGOT; A-AGO; MITO; MANGO; GEICO).

Staff members:

Jalid Sehouli, MD, PhD (Chair of P3 a) has a striking clinical expertise track record in gynaecological oncology. He is active in scientific research as the initiator and leader of the TOC network and of several Phase I to Phase III clinical trials. He led the WP biobanking within the OVCAD and OCTIPS consortium. Radoslav Chekerov, MD, is a physician with strong expertise in the systemic treatment of ovarian cancer, directing the chemotherapy ambulatory clinic in our Department. Elena Ioana Braicu, MD, is a physician working in the field of ovarian cancer. Isil Yalcinkaya, is coordinating the clinical trial unit and has a large experience in coordinating Phase I to Phase III clinical trials.

b) Charité Department of Gynaecology – Tumor Bank Ovarian Cancer

Description:

Our Tumor Bank Ovarian Cancer Network (TOC –www.toc-network.de) was established in 2004. More than 10 high volume centers, from 6 countries, are recruiting patients for the Bio-bank. With more than 4500 patients enrolled, our virtual biobank is the largest bio-repository for ovarian cancer world wide. Within this biobank, tissue (fresh frozen or FFPE samples), ascites, plasma and serum are collected. TOC has established SOPs for sample collections and clinical data documentation, including the intraoperative mapping for ovarian cancer (IMO tool). Our consortium has close cooperation with international research centers and national, European and international study groups such as ENGOT; ESGO; GCIG. The coordinatory center of TOC is located at Chaité medical University, and was involved in coordinating the biobnaking work packages in 3 different European projects.

Staff members:

Jalid Sehouli, MD, PhD director of the department for gynecology and Charité Campus Virchow Klinikum. He initiated the TOC Network and EUTROC project. Elena Ioana Braicu, MD, is a physician working in the field of ovarian cancer. He is leading the TOC Network and translational research at the department of gynecology, Charité Medical University. Her main topic are biomarkers, early detection and diagnostic, predictive biomarkers for therapy response and surgical outcome of ovarian caner. She is treasurer for EUTROC Network, and member of the NOGGO and AGO study group. He took part in OVCAD and OCTIPS European projects, and coordinated the biobanking WPs. Radoslav Chekerov, MD, is a physician with strong expertise in the systemic treatment of ovarian cancer. Monika Mentze, is our medical technician being involved in all biobanking procedures.

c) The Institute of Pathology

Description:

The Institute of Pathology of the Charité was founded in 1856 by Rudolf Virchow as the first pathological institute in Germany. 75.000 tissue samples from all three campi of the Charité Medical University are histopathologically investigated here each year. The Translational Cancer Research Group evaluates multilevel biomarkers from tissue samples, focusing on predictive and prognostic biomarkers in ovarian and breast cancer. The group has a high expertise in the high-throughput processing of fresh-frozen and FFPE tissue samples for tissue micro array (TMA) production and nucleic acids extraction. Immunohistochemistry, real-time PCR, and DNA sequencing methods are well established in the lab. The Translational Cancer Research Group tightly cooperates with the TOC lab group of the Department of Gynecology since many years. pathologie-ccm.charite.de/forschung/ag_translationale_tumorforschung_und_molekulare_pathologie/

Staff members:

Silvia Darb-Esfahani, MD, is a senior pathologist with a focus on gynecological pathology. Wolfgang Schmitt, MD, is a pathologist with a focus on biomarkers in ovarian and breast cancer.

Description:

The Universiaetsklinikum Hamburg-Eppendorf hosts the largest comprehensive cancer centre in northern Germany and is a top-ranked hospital in the EU. The Department of Gynaecology and Gynaecologic Oncology is a tertiary centre treating more than 100 ovarian cancer patients per year and was one of the first certified gynaecologic cancer centres in Germany. A tumour bank with fresh-frozen and paraffin-embedded tissue-samples has been established in 1996. The Department currently participates in several phase I/II and III trials in ovarian cancer. It has continuously ranked among the top 3 recruiting centres in Germany over the past years and also performs several on-going trials in other gynaecologic malignancies (including vulvar-, cervical and endometrial cancer) and in breast cancer. At the integrated molecular laboratory two molecular biologists and several PhD students perform translational research projects on gynaecologic malignancies and the Department of Gynaecology is publishing more than 60 papers per year in peer reviewed journals. The Universiaetsklinikum Hamburg-Eppendorf has successfully been involved in the EU FP6 OVCAD project. Currently the Department is involved in many ovarian cancer trials within the AGO-gynaecological Cancer Study-Group, ENGOT (European Network of Gynaecological Trial groups) and GCIG (Gynaecologic Cancer Inter-Group), and in industry trials in ovarian cancer and other gynaecologic malignancies.

Staff members:

Sven Mahner, MD, has long-standing expertise in clinical phase I/II and III trials in ovarian cancer and in translational research. He is a member of the steering committee and executive board of the AGO-OVAR study group and represents this group in the Gynaecologic Cancer Intergroup (GCIG). He has authored more than 60 original full papers in peer-reviewed journals and several book chapters on Gynaecologic Oncology and received numerous awards for his research. Linn Woelber, MD, Fabian Trillsch, MD, and Donata Grimm, MD, are physicians performing a fellowship in Gynaecologic Oncology, and actively perform translational research in ovarian cancer.

Description:

Founded in 1365 as Medical Faculty of the University of Vienna, the MUW is now one of the world’s largest and most renowned medical universities (www.meduniwien.ac.at). Two Units within the legal entity MUW have distinct and important roles in GANNET53 trial:

a) Department of General Gynaecology and Gynaecologic Oncology

The Department of General Gynaecology and Gynaecologic Oncology is a treatment centre of gynaecological cancers, treating about 45 new cases of ovarian cancer yearly.

Staff members:

Alexander Reinthaller, MD, PhD, is the head of the Gynaecologic Cancer Unit of the Department for General Gynaecology and Gynaecologic Oncology. He is an experienced gynaecologic oncologist, a board-approved clinical trial investigator and PI of >30 Phase II-III clinical trials. He is former president of the A-AGO trial group and cooperating with several international academic institutions. Heinz Kölbl, MD, PhD, chairs the Department of General Gynaecology and Gynaecologic Oncology. He is a leading expert in gynaecologic oncology and highly experienced in the design and conduction of clinical studies. Stephan Polterauer, MD, PhD is a gynaecologist and physician scientist with focus on gynaecological oncology. He participates and leads a high number of clinical and investigational studies in gynaecological oncology and has performed a research-fellowship at the Memorial Sloan-Kettering Cancer Center, New York, NY.

b) Molecular Oncology Group

The Molecular Oncology Group was founded by Robert Zeillinger more than 20 years ago. It is focusing on molecular oncology research, especially biomarker identification and validation. p53 is an important topic since the beginning. The group established a functional p53 assay (FASAY) for rapid mutation detection and identified new p53 splice variants. The laboratory is well equipped with various basic and advanced lab instruments and has access to deep sequencing, microarray platforms and other high-tech equipment in the core facility of the university. The main topics of the laboratory are: detection and characterization of circulating tumour cells (CTCs) in gynaecologic cancers, identification and validation of signatures consisting of mRNA and protein biomarkers for early cancer diagnosis, therapy prediction and monitoring, and prognosis. Robert Zeillinger has established the “OVCAD” consortium and has successfully coordinated this EU FP6 research project. The Molecular Oncology Group participates in TOC (Tumourbank Ovarian Cancer) and EUTROC (European Network for Translational Research in Ovarian Cancer) and Robert Zeillinger is member of their scientific boards.

Staff members:

Robert Zeillinger, PhD, is Head of the Molecular Oncology Group of MUW. He is also the group leader of P12 (please see participant 12). Eva Obermayr, PhD, is an expert in isolation and detection of circulating tumour cells. She identified mRNA signatures for detecting CTCs in blood samples of patients with ovarian, breast, endometrial, and cervical cancer. She also has strong expertise in molecular characterisation of CTCs, and recently specifically identified Cyclophilin C as a strong prognostic biomarker in CTCs. Elis­a­beth Mar­itschnegg, PhD stu­dent, has received her Master’s degree in Mol­e­c­u­lar Micro­bi­ol­ogy from the Uni­ver­sity of Graz, Aus­tria. In her doc­toral the­sis she is work­ing on the mol­e­c­u­lar detec­tion and char­ac­ter­i­sa­tion of CTCs from dif­fer­ent types of can­cer. Christiane Agreitner

Description:

The Assistance Publique des Hôpitaux de Paris (AP-HP) includes most of the academic centres of Paris and surroundings, ie. 37 academic centres organised into 12 hospital groups. The 2 biggest centres for gynaecology oncology research in AP-HP are Hôpital Tenon and Hôpital Hôtel-Dieu. Currently the two Departments are involved in many ovarian cancer trials within the GINECO group, ENGOT (European Network of Gynaecological Trial groups) and GCIG (intergroup), and in industry trials in gynaecologic cancer.

Hôpitaux de Paris participates with two hospitals in the GANNET53 trial

a) Hôpital Hôtel-Dieu: Medical Oncology Department

Description:

The Hôtel-Dieu is an academic hospital within AP-HP. The Medical Oncology Department (Eric Pujade-Lauraine) is mainly dedicated to gynaecological cancer research in addition to patient care and education, and is one of the top clinical research centres in France. The Department is treating more than 100 new ovarian cancer patients per year. The GINECO ovarian cancer tumour bank has been constructed during the past 15 years with tissue samples from >1,000 ovarian tumours. The Department currently participates in more than 25 phase I-II or III trials in cancer patients and around 10 trials are dedicated to gynaecologic cancers, involving many new molecular targeted drugs. The Medical Oncology Department is publishing around 10 to 15 papers focusing on gynaecology oncology per year in peer reviewed journals.

Staff members:

Eric Pujade-Lauraine, MD, PhD, is the Chair of GCIG (Gynaecological Cancer Intergroup), which is the umbrella under which all cooperative groups focusing on gynaecological cancer world-wide are organised. He is also member of the board of the ENGOT (European Network of Gynaecology Oncology Trial), member of the American NCI Gynaecological Cancer Steering Committee, and the Chair of the AP-HP National Rare Gynaecological Tumour Reference Centre of AP-HP. He has authored more than 130 original full papers in peer-reviewed journals. Jerôme Alexandre, MD, PhD, Jean-Marie.Tigaud, MD, Laure Chauvenet, MD, Charles Chapron, MD, PhD, Fréderic Borghèse, MD, PhD, are physicians involved in clinical trials in gynaecologic oncology. Marie-Cécile Vacher-lavenu MD, PhD (pathologist) is the Chair of the French network of pathologists dedicated to gynaecology oncology.

b) Hôpital Tenon: Medical Oncology Department

Description:

The Hôpital Tenon is an academic hospital within AP-HP. One of the main activities of the Medical Oncology Department (Jean-Pierre Lotz) is gynaecological cancer research in addition to patient care and education (Fréderic Selle), and is also one of the top clinical research centres in France. The Department is treating more than 150 new ovarian cancer patients per year and more than 500 new gynaecological cancer patients each year. The Medical Department currently participates in more than 50 phase I-II or III trials in cancer patients and around 10 trials are dedicated to gynaecologic cancers.

Staff members:

Frederic Selle, MD, is member of the scientific committee of the GINECO group, part of the board of the Rare Gynaecological Tumour Reference Centre of the AP-HP and chair of the medical committee of gynaecology cancer in Hôpital Tenon. He has authored more than 130 original full papers in peer-reviewed journals. Emile Darai, MD, PhD, Marcos Ballester, MD, Nathalie Chabert MD, PhD, Claude Arf, MD, Karine Beerblock, MD, are physicians involved in clinical trials in gynaecologic oncology. Annie Cortez, MD, (pathologist) is part of the AP-HP network of pathologists dedicated to gynaecology oncology.

Description:

The Centre Anticancereux Léon Bérard is a Comprehensive Cancer Centre dedicated to research, patient care and education, and is one of the top-ranked hospitals in the EU. The Department of Adult Medical Oncology is tertiary centre treating more than 100 new ovarian cancer patients per year. A tumour bank has been constructed in the past 10 years with tissue samples from 170 ovarian tumours. The Department currently participates in more than 100 phase I-II or III trials in cancer patients and more than 10 are dedicated to gynaecologic cancers. The division of Medical Oncology Department is publishing more than 100 papers per year in peer - reviewed journals. The Centre Anticancereux Léon Bérard has been successfully involved in the EU FP6 OVCAD, HERMIONE and CHILDHOPE projects and is involved in the EU FP7 OCTIPS project. Currently the Department participates in many ovarian cancer trials within the GINECO group, ENGOT (European Network of Gynaecological Trial groups) and GCIG, and in industry trials in gynaecologic cancer.

Staff members:

Isabelle Ray-Coquard, MD, PhD, is the current Chair of the GINECO, the Chairman of the rare-tumour working group of GCIG, the Chairman of the multidisciplinary staff dedicated to gynaecologic cancer (CLB) and the national co-coordinator of the rare ovarian cancer network supported by the InCA (French NCI). She has authored more than 200 original full papers in peer reviewed journals, 10 book chapters, and edited several books on Gynaecological Oncology. Olivier Tredan, MD, PhD, Pierre Heudel, MD, Pierre Meeus MD, Nicolas Chopin, MD, Fréderic Beurrier, MD, and Nicolas Carrabin MD (gynaecological surgeons) are physicians involved in clinical trials dedicated to gynaecologic oncology. Isabelle Treilleux, MD, PhD, (pathologist) and Nathalie.Bendriss, PhD (researcher) are involved in the organisation of translational research dedicated to gynaecologic cancers. Alice Levrard, MD, and Nathalie Bonnin, MD, are Fellows in medical oncology focusing on gynaecologic cancers and involved in Clinical trials Phases I to III.

Description:

The main duties of the AGO study group are initiating and processing clinical trials in gynaecologic tumours, organisation of educationals courses and networking in national and international expert panels. The group was founded in 1993. AGO Research GmbH is the legal entity and the operational structure of the AGO study group. The organizational structure includes members of the study leading group and the executive board. With more than 250 institutions (hospitals, centres of excellence etc.) and in alliance with cooperative networking as the GCIG (Gynaecologic Cancer Intergroup) and the ENGOT (European Network of Gynaecological Oncological Trial Groupsthe AGO study group is one of the strongest groups in the field of gynaecologic cancers worldwide. One of the founding members of AGO Study Group, Andreas du Bois, currently holds the ENGOT chair. Until today more than 50 clinical trials in phase I to phase III in the area of gynecologic tumours have been conducted. The AGO study group is involved in high innovative clinical trials which have also brought valuable results are part of changing gold standard in the treatment of ovarian cancer.

Staff members:

Andreas du Bois, MD, PhD, and Jacobus Pfisterer, MD, PhD (Kiel, Germany) are the speakers of the AGO study group. Both are members of ENGOT, GCIG and the German Cancer Society (Deutsche Krebsgesellschaft), reviewers of several scientific journals, and are the lead Investigators for the AGO study group in several multi-national, multi-centre clinical trials. Sven Mahner, MD, PhD, (see Participant 4) is an experienced gynaecologic oncologist and member of the AGO study group. He will lead this national trial group in the GANNET53 project. Stefanie Barth, Chief Executive Officer (CEO), Gabriele Elser, Head of Study Office

Description:

NOGGO was founded in 1998 in Berlin as an interdisciplinary and interprofessional society with the aim to improve the life expectancy and recurrence-free survival among different tumour entities, decisively with special consideration given to the quality of life. Today, NOGGO has 700 members who use the Continuing Education offers and participate actively in working groups or clinical trials of the society. Based on the primary objective, NOGGO designs and conducts extensive clinical studies on the requirements of Good Clinical Practice to various gynaecological tumour types at the national and international level. Since many years the NOGGO has a proven track record in the conception, realisation, evaluation and interpretation of controlled mono- and multicentric studies. NOGGO is a member of ENGOT and GCIG. In addition, NOGGO maintains strong international and interdisciplinary cooperations with different working groups and tumour centres in Europe, the US, Asia and Africa. In the last 5 years NOGGO initiated several international studies in collaboration with other groups such as the G-AGO group. At present, NOGGO has four clinical trials Phase I to Phase III running in recurrent ovarian cancer and one Phase II clinical trial in newly diagnosed ovarian cancers.

Staff members:

Jalid Sehouli, MD, PhD, has extensive clinical expertise in gynaecological oncology, especially in ovarian cancer, and is the initiator and leader of many clinical trials. He published more than 230 peer-reviewed articles. Professor Sehouli is a member in NOGGO and in other national and international study groups. His contributions to the field of ovarian cancer have been exceptional. He will lead NOGGO in the GANNET53 project. Werner Lichtenegger, MD, PhD is the actual president of the NOGGO society and the former director of the Gynaecological Department at Charité. Prof. Lichtenegger has outstanding experience and knowledge in gynaecological malignancies, and was involved in key decisions of several Phase I to Phase III clinical trials. Maren Keller, PhD, is the general actual leader for clinical trials of the NOGGO society. She has studied biotechnology and has a long experience in regulatory affairs for clinical trials.

Description:

The gynaecological cancer cooperative group was created in 1993 by Eric Pujade-Lauraine, JP Guastalla, and P. Vincent. GINECO is a cooperative clinical trials group of clinicians dedicated to gynaecological cancer research in France and stands for Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens. ARCAGY is the legal entity and the operational structure of the GINECO group. ARCAGY-GINECO is a non-profit organisation. More than 700 investigators of more than 150 centres (public or private) participate in ARGAGY-GINECO. To date, the ARCAGY-GINECO group is the only group dedicated to gynaecological cancer research in France. It has been labelled by INCA (Institut National du Cancer) as the only “French cooperative intergroup focusing on cancer with international scope” dedicated to gynaecological cancers. Organisational structure of the scientific gynaecological oncology cooperative group:

• Scientific Committee (about 30 regional leaders)
• Eight working groups, each representing a specific organ localization or domain: 1) Ovarian cancer, first line 2) Ovarian cancer, relapse 3) Uterus: cervix and endometrium 4) Rare gynaecologic tumours 5) Elderly patients 6) Surgery 7) Pathology 8) Translational research

The Scientific Committee and the working groups are the collective intellectual vehicle of the GINECO. New clinical trial proposals are first discussed in the respective working groups before being presented and discussed in the Scientific Committee. Each project is validated by the Scientific Committee and is not implemented if it does not follow the scientific strategy of the group. Since its creation, the group has been involved in more than 50 research protocols, of which 20 are still ongoing. The ARCAGY-GINECO database includes more than 5.000 patients. Yearly 3 to 5 new trials are implemented, allowing 5 to 10 trials to be active for recruitment each year. Globally, 60 to 80 sites are active each year.

Staff members:

Eric Pujade-Lauraine, MD, PhD and Frederic Selle, MD (see Participant 6) The leadership of the GINECO includes 3 people in the role of Chair (Isabelle Ray-Coquard, MD, PhD in 2012), co-Chair (G. Freyer) and Past Chair (A.C. Hardy-Bessard). The chair is elected for 1 year as co-chair, 1 year as chair and 1 year as pastchair. Thanks to its operational structure, ARCAGY-GINECO has the operational capacity to design, promote and carry out clinical trials in France as well as worldwide, and to disseminate the results worldwide. The operational structure, directed by Bénédicte Votan, includes 16 people dedicated to gynaecological cancer clinical trials.

Description:

Göttingen University has a strong international reputation, ranked 9th in Europe and 43rd in the world in 2010 by the renowned British Times Higher Education World University Rankings. Its scientific facilities include state-of-the-art Genomics, Deep Sequencing, Proteomics, Bioinformatics and 3D Animal Imaging Facilities. Göttingen University Hospital is the largest in Lower-Saxony and includes the interdisciplinary Göttingen Comprehensive Cancer Centre (G-CCC). The Institute of Molecular Oncology, the main research arm of the G-CCC, focuses on basic and translational cancer research. It consists of 3 research groups (Dobbelstein, Moll and Bastians). It has excellent new facilities for the required work and has a large panel of ovarian cancer cell lines, advanced Animal Research Facilities, a Biobank, GRID computing and a Digital Research Archive. In 2007 Ute Moll accepted a guest professorship in the Department and founded a new research group, while maintaining her original lab in the USA (Stony Brook University, New York).

Staff members:

Ute Moll, MD, MS is a world-renowned p53 and cancer researcher at Göttingen University. Her research focus is on function and regulation of the p53/p63/p73 family of tumour suppressors, as well as on the tumor-promoting role of MIF (macrophage migration inhibtory factor). She is also a board-certified anatomic and clinical pathologist, and her work has a strong translational direction. She is the Principal Investigator of a continuously productive, well-funded research laboratory since 20 years, including multiple successfully completed projects with uninterrupted grant support from the US National Cancer Institute, New York State Health Research Board, American Cancer Society, Deutsche Forschungsgemeinschaft and Krebshilfe, among others. She mentored and trained > 40 graduate students and postdocs (eg Nicole Concin (P1) trained as postdoctoral fellow with Ute Moll) and authored over 142 peer-reviewed high impact papers in cancer including ovarian cancer and development (cited . 8,000 times with an h-index of 43 and a combined Total Impact Factor of 769). She regularly gives invited lectures at international meetings and often serves as co-organizer of international meetings. Daniela Kramer, a new postdoctoral fellow of the Moll group, did her PhD thesis in the Dobbelstein group in Göttingen, in which she characterized several molecular mechansims of p53-family members, in particular the p73 homolog. Link to the Moll lab: http://www.moloncol.med.uni-goettingen.de/content/researchgroups/26.html

Description:

OncoLab Diagnostics GmbH is a spin-off of ViennaLab Diagnostics GmbH (www.viennalab.com), an in vitro diagnostics company based in Vienna, Austria. The CEO of P12, Dr. Robert Zeillinger, was founder and CEO of ViennaLab which he successfully led until its sale in 2010, driving the company’s focus to the commercialisation of promising diagnostic tests. He is now the CEO of P12 which he founded to cover the oncological branch of in vitro diagnostics. Since it became operative in 2011 OncoLab was awarded two national grants, enabling commencement of R&D for the development of diagnostic tests for different types of cancer. The focus of the company lies in the development, manufacturing and marketing of competitive tests for Early Detection of Cancer and Therapy as well as Post-Therapy Monitoring of Anti-cancer Treatment. P12 and its founder currently hold 7 industrial property rights.

Staff members:

Dr. Robert Zeillinger, PhD, has a strong background in cancer research, holding a leading position at the Medical University of Vienna, Austria, where he heads the Molecular Oncology Group at the Department for Obstetrics and Gynecology. Being active for more than 25 years in both academic and industrial research he is now a renowned scientist and proven leader of interdisciplinary, multinational teams. His distinguished scientific expertise is complemented by a founded experience in partnering research projects of the EC framework programmes FP6 and FP7. He is author and co-author of more than 200 scientific publications. Gabriele Klaming, MA, is COO of OncoLab. She worked in international project management, legal translation and as a knowledge manager and organises and administrates the daily operations of the start-up company OncoLab. Elisabeth Maritschnegg, PhD student, has received her master’s degree in Molecular Microbiology from the University of Graz, Austria. In her doctoral thesis, she works on the molecular detection and characterisation of cancer cells from different types of cancer.

Description:

Founded in 2006 by Salvatore Vanasco and Laszlo Puskas, xailabs specialises in developing state-of-the-art customer-tailored software systems. xailabs’ client base lists market industry leaders such as Deutsche Telekom, Vodafone, McFit, as well as hidden champions from the Small and Medium Business Sector (SMB). xailabs also cooperates with medical institutes and networks such as the Charité and the Tumour bank Ovarian Cancer Network (TOC) to identify, specify and develop tomorrows’ medical IT solutions.

xailabs’ experienced staff of 35 employees has a proven track record of:

• High scalable portal solutions for the medical and enterprise sector
• User-Interface and Experience Design
• Middleware components
• Mobile applications for multiple platforms (Apple iOS, Android, Blackberry etc.)
• Application Programming Interface (API) development
• Organized in four departments: consulting, creation, development and support, who work closely together to guarantee maximum project effectiveness and efficiency. They operate Europe-wide from their headquarters in Berlin and also run well-equipped project offices in Hamburg, Stuttgart and Düsseldorf.

Staff members:

Salvatore Vanasco - Head of Operations, Communications Manager. Salvatore is the founder and Chief Executive Officer (CEO) of xailabs with a track record of more than 25 years in software development projects. He holds a degree in visual communications and is a respected innovator, constantly exploring improved methods of communication and interaction utilizing software systems. Laszlo Puskas - Head of IT, Project Management. Laszlo Puskas studied computer science at the Technical University Berlin. He is the Head of IT and Project Management at xailabs. With his vast experience of more than 25 years in the IT-Business, he brings a valuable asset to every project whether it is process consulting or software architecture.

Description:

The Kliniken Essen Mitte (KEM) is a specialised interdisciplinary cancer centre which hosts one of the largest and scientifically most active Department of Gynaecologic Oncology in Germany. The aim of KEM is to become a Comprehensive Cancer Centre. In early 2011 Andreas du Bois was appointed Head of the Department of Gynaecologic Oncology. Since KEM is also a highly recognized centre of surgical excellence, many German medical fellows visit KEM to learn about surgical standards of therapy. Each year more than 300 ovarian cancer patients receive operative or systemic therapy at the KEM. Under the supervision of Andreas du Bois more than 1,500 patients have received treatment within prospective clinical trials.

• The KEM is closely linked to the AGO study group trial group. KEM hosts three gynaecologic oncologists who are principle investigators of international prospective clinical trials and who are members of the AGO study group executive board. For coordination purposes, parts of the AGO office moved into the proximity of KEM.
• The infrastructure of KEM assures that a large fraction of gynaecologic oncology patients receive treatment within clinical study protocols. The Department of Gynaecologic Oncology is currently recruiting patients for seven prospective phase II or phase III clinical trials.
• KEM has extensive experience in conducting Phase I-III trials and all operational tasks to collect and process tumour tissue samples are working efficiently.

Staff members:

Andreas du Bois, MD, chairs the Department of Gynaecologic Oncology at KEM and is the president of ENGOT, the European assembly of study groups in gynaecologic oncology. Several international multi-centre clinical studies are currently led by him or by gynaecologic oncologists of his Department. He is author of more than 300 peer-reviewed publications and member of several editorial boards and study steering committees. Christian Kurzeder, MD, Gynaecologic Oncologist, is involved in the medical and surgical care of patients with breast and gynaecological cancers. He is a member of the AGO-Ovar working group of the G-AGO group. He also serves as the international coordinator of the AGO-Ovar 2.20 Study and as German national principle investigator of the AGO-Ovar 2.19 study. Both studies are collaborative studies carried out by the European Network of Gynaecologic Oncology (ENGOT). He is author of more than 30 peer-reviewed publications and member of several study steering committees. Florian Heitz, MD, Fellow in gynaecologic oncology, involved in the medical and surgical care of patients with breast and gynaecological cancers. He is principle investigator of the Ovarian Symptom Benefit Study and is author of more than 10 peer reviewed publications. Philipp Harter, MD, is a Senior physician in gynaecologic oncology and involved in gynaeclogic endoscopic surgery and surgical and medical therapy of patients with gynaecological cancers. He is a member of various Medical Societies and as member the AGO study group he is the scientific lead of several studies on the surgical therapy and chemotherapy of pelvic tumors.

Description:

The University Hospital Carl Gustav Carus Dresden is dedicated to research in addition to patient care and education, making it one of the top-ranked hospitals in Germany. The Comprehensive Cancer Centre of the university hospital and the medical faculty integrates all cancer treating specialties. The Department of Gynaecology and Obstetrics is approved as Gynaecologic Cancer Centre. In the Department of Gynaecology and Obstetrics > 60 new diagnosed ovarian cancer patients are being treated per year, in addition to ovarian cancer patients who present at time of relapse. A large tumour bank has been constructed by the university hospital. The Department of Gynaecology and Obstetrics is one of the leading centres of the AGO study group since many years and participated in more than 15 phase II and III trials in ovarian cancer, involving many new molecular targeted drugs. Results of research focussing on ovarian cancer are regularly published in peer-reviewed journals.

Staff members:

Pauline Wimberger, MD, PhD, is the head of the Department of Gynaecology and Obstetrics of the University Hospital Carl Gustav Carus Dresden. She participated in more than 50 clinical trials and published many original papers in the field of ovarian cancer research. She is member of G-AGO, AGO Kommission OVAR, German Society of Gynaecology and Obstetrics (DGGG), German Cancer Society (DKG) European Society of Gynaecological Oncology (ESGO), American Society of Clinical Oncology (ASCO) and European Society of Breast Cancer Specialists (EUSOMA). Ulrich Canzler, MD, is consultant in gynaecologic oncology and principal investigator of more than 15 clinical trials. He is member of G-AGO, German Society of Gynaecology and Obstetrics (DGGG), North-Eastern German Society of Gynaecological Oncology (NOGGO) and the German Cancer Society (DKG). Karin Kast, MD, is consultant in gynaecologic oncology and principal investigator of many clinical trials. She is head of the Familial Breast- and Ovarian Cancer Centre Dresden and member of the International BRCA1/2 Carrier Cohort Study (IBCCS), Consortium of Investigators of Modifiers of BRCA1/2 (CIMBA) and German Society of Gynaecology and Obstetrics (DGGG).

Description:

The CFB is a Comprehensive Cancer Centre based in Normandie, France. CFB is dedicated to patient care, education and research. Its clinical Department of Development of Early Phase Trials has been recognized by INCA (French National Cancer institute) in 2010 to be among the 16 national clinical research centres dedicated to develop new drugs. A clinical unit has been created in 2011 to treat patients in clinical trials with a specific team of physicians and nurses. The Multidisciplinary Department of Gynaecologic Oncology includes specialists in medical oncology, radiotherapy, imaging and surgery. More than 85 new ovarian cancer patients are treated per year, in addition to about 80 ovarian cancer patients per year who present at time of relapse. The Department of Gynaecologic Oncology currently participates in more than 10 phase I-II or III trials specifically in gynaecological cancers (among the 145 trials open in the Clinical Research Department). A university-integrated laboratory of experimental Gynaecology Oncology (BIOTICLA) works with the clinical team on apoptosis and chemotherapy resistance in ovarian cancer. This team includes 5 researchers and more than 5 students currently performing translational research on gynaecological cancer. The Division of Gynaecological Cancer Research is publishing regularly in publications in peer-reviewed journals. A large tumour bank has been constructed in the past 10 years with tissue samples from around 300 ovarian tumours. The Department is involved in many ovarian cancer trials within the GINECO Group, the EORTC-gynaecological Cancer Group, ENGOT (European Network of Gynaecological Trial groups and GCIG (International Gynaecological Oncology Group), and in industry trials in ovarian cancer.

Staff members:

Florence Joly, MD, PhD, is the Chief of the Clinical Research Department of Centre Francois Baclesse, Caen. She is a medical Oncologist dedicated to Gyneco-oncology and Uro-oncology. She is a member of the scientific committee of the GINECO group, France. She is chair of the Symptom Benefit Group for the International GCIG. She is author or co-author of more than 80 full papers in peer-reviewed journals, together with some book chapters. She is also a scientific reviewer for numerous Journals (e.g. Cancer, International Journal of Gynaecological Cancer, Annals of Oncology, Gynaecologic Oncology, Journal of Clinical Oncology). Stephanie Lheureux, MD, PhD, performs translational research in ovarian cancer. Laurent Poulain, PhD, coordinates the Laboratory of preclinical research at BIOTICLA.

Roselyne MOSTIER (Infirmière de recherche clinique) Astrid LETIEMBRE (Attachée de recherche clinique) Aurélie BOUST (Infirmière de recherche clinique) Florence JOLY-LOBBEDEZ (PuPH responsable de l'unité de recherche clinique) Sandrine VIVIER (médecin unité d'hospitalisation recherche clinique)

Description: The Medical University Greifswald is one of the oldest in Germany and was founded in 1456. Today the Medical University Greifswald is one of the biggest hospitals in the north of Germany with 21 clinics, 19 institutes and additional research centres. The hospital has 880 beds and in 2009 treated 147,000 patients. The Department of Gynaecology and Obstetrics is composed of different units and treats all types of gynaecological cancers as well as breast cancer. The Department of Gynaecology and Obstetrics has long-standing experience in the clinical care and translational research of ovarian cancer, taking part in many Phase II and III clinical trials for gynaecological malignancies and ovarian cancer in particular. The Department of Gynaecology and Obstetrics is linked to the major national and international trial groups (e.g. AGO study group, NOGGO, and EORTC). The research laboratory conducts extensive epigenetic and genetic research in the field of Gynaecology and Oncology. The laboratory has excellent facilities for advanced high-level genomic and epigenomic analysis. Since 2004 the Department of Gynaecology and Obstetrics is part of the international multi-centre tumour bank ovarian cancer network (TOC, www.tocnetwork.de). This centre is one of the key partners in the EU FP7 RAIDs project.

Staff members:

Alexander Mustea, MD, PhD, head of gynaecologic tumour center pomerania, co-chairs the Department of Gynaecology and Obstetrics and has outstanding clinical expertise in gynaecological oncology. He is active in scientific research as the initiator and leader of several Phase II and Phase III clinical trials. He was involved in the EU FP6 OVCAD consortium and is a member of the FP7 RAIDs consortium. Dominique Koensgen, MD, PhD, is a physician working in the field of ovarian cancer. She is leading the tumour-banking program for ovarian, cervical and endometrial cancer and leads the translational research within the group. She was involved in the OVCAD consortium and is a member of the RAIDs consortium. Salvatore Delogu, PhD, is a Biologist with strong experience in research focused on prognostic and predictive factors in malignancies, and in particular in ovarian cancer.

Description:

The Department of Obstetrics and Gynaecology of the Medical University of Magdeburg represents a centre for treatment of gynaecological malignancies and breast cancer in Germany. The major focus is the multi-modal interdisciplinary approach in advanced stages of gynaecological malignancies and breast cancer. Since many years the institution is involved in numerous Phase I to III clinical trials. About 80 patients are enrolled yearly into clinical trials. In the field of ovarian and breast cancer, two members of the scientific team play an active role in oncological working groups such as NOGGO, AGO study group, and GCIC.

Staff members:

Joachim Bischoff, MD, PhD, is specialised in medical treatment of gynaecological oncology patients. He has conducted several Phase I/II trials in metastatic breast cancer evaluating the implementation of modern cytotoxics and targeted agents in this setting. He is investigator in several Phase I-III NOGGO and AGO study group clinical trials recruiting ovarian cancer patients. Moreover, he is the principle investigator for several multinational Phase III clinical studies within the field of breast cancer in Germany. Kerstin Wollschlaeger, MD, is a physician with clinical experience especially in ovarian cancer. She has spent many years actively working within the AGO study group and today she has a leading role in all clinical trials in ovarian cancer (Phases II and III) as Co-Investigator at Magdeburg University.