Genomic BRCA and Extensive ovArian Cancer Testing (GREAT)

December 13, 2023 updated by: ARCAGY/ GINECO GROUP

Cohort Study to Evaluate the Clinical Features of Patients With Epithelial Ovarian Cancer Depending on Tumoral Mutation of BRCA or Beyond BRCA Genomic Molecular Abnormalities

This is a prospective observational French multicenter cohort in patients with ovarian and/or primitive peritoneal and/or fallopian tubes carcinoma, histologically confirmed, with an advanced stage at diagnosis (stage III to IV FIGO 2014). The objective is to constitute a clinico-biological database that allows to correlate clinical and progressive features of ovarian cancer patients based on tumor genomics and molecular detected abnormalities.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a prospective observational French multicenter cohort in patients with ovarian and/or primitive peritoneal and/or fallopian tubes carcinoma, histologically confirmed, with an advanced stage at diagnosis (stage III to IV FIGO 2014). The objective is to constitute a clinico-biological database that allows to correlate clinical and progressive features of ovarian cancer patients based on tumor genomics and molecular detected abnormalities.

Study Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France, 47000
        • Centre de Radiothérapie et d'Oncologie de Moyenne Garonne (CROMG)
      • Aix-en-Provence, France
        • Centre Hospitalier Général d'Aix-en-Provence
      • Aix-en-provence, France, 13080
        • Hôpital Privé d'Aix en Provence
      • Amiens, France
        • CHU Amiens
      • Amiens, France
        • Clinique Victor PAUCHET
      • Angers, France
        • Institut de Cancérologie de l'Ouest - ICO
      • Antony, France, 92160
        • Hôpital Privé d'Antony - Ramsay Santé
      • Arras, France
        • CH Arras
      • Auxerre, France
        • Ch Auxerre
      • Avignon, France
        • Institut Sainte Catherine
      • Bayonne, France
        • CH Cote Basque
      • Bayonne, France, 64100
        • Clinique Belharra
      • Beauvais, France, 60021
        • Centre Hospitalier de Beauvais
      • Besançon, France
        • CHRU Jean Minjoz
      • Blois, France
        • CH de Blois
      • Bobigny, France, 93009
        • Hôpital Avicenne
      • Bordeaux, France
        • Institut Bergonie
      • Bordeaux, France
        • Clinique Tivoli
      • Bordeaux, France
        • Polyclinique Bordeaux Nord
      • Bordeaux, France
        • CHU de Bordeaux - Hôpital Pellegrin
      • Bourg-en-Bresse, France
        • CH Bourg en Bresse
      • Brest, France
        • CHU Brest
      • Bron, France, 89500
        • Hopital Femme Mere Enfant
      • Caen, France
        • Centre Francois Baclesse
      • Caen, France
        • Centre Maurice Tubiana
      • Cahors, France
        • CH de Cahors
      • Carcassonne, France
        • CH Carcassonne
      • Castres, France
        • Hôpital Général de Castres
      • Challes-les-Eaux, France
        • Médipôle de Savoie
      • Chalon-sur-Saône, France
        • CH Chalon sur Saône
      • Chambray-lès-Tours, France
        • Centre d'Oncologie et de Radiothérapie 37
      • Chambéry, France
        • CH Metropole Savoie
      • Cherbourg, France
        • CHPC - Hôpital Louis Pasteur
      • Cholet, France
        • Ch Cholet
      • Châteauroux, France, 36000
        • Centre Hospitalier de Chateauroux
      • Clamart, France
        • Hôpital Antoine Béclère
      • Clermont-Ferrand, France
        • Centre Jean Perrin
      • Contamine-sur-Arve, France
        • CH Alpes Léman
      • Corbeil-Essonnes, France, 91106
        • Centre Hospitalier Sud Francilien (Site Gilles de Corbeil)
      • Cornebarrieu, France, 31700
        • Clinique des Cèdres
      • Coudekerque-Branche, France
        • Clinique de Flandre
      • Creil, France
        • Groupe Hospitalier public du Sud de l'Oise (GHPSO)
      • Créteil, France
        • CHI Creteil
      • Dijon, France
        • CHU Dijon
      • Dijon, France
        • Centre Georges Francois Leclerc
      • Dijon, France
        • Institut de Cancérologie de Bourgogne - GRReCC
      • Fréjus, France, 83600
        • Centre Hospitalier Intercommunal de Fréjus Saint Raphael
      • Grenoble, France
        • GH Mutualiste de Grenoble
      • Guilherand-Granges, France, 07500
        • Hôpital privé Drôme Ardèche - Clinique Pasteur
      • Jossigny, France
        • Centre Hospitalier Marne-la-Vallée
      • La Roche-sur-Yon, France, 85925
        • Centre Hospitalier Departemental de Vendee
      • La Tronche, France
        • CHU Grenoble Alpes - Site Nord (La Tronche)
      • Le Chesnay, France
        • Hopital Andre Mignot
      • Le Coudray, France
        • Les Hôpitaux de Chartres
      • Le Havre, France, 76600
        • Hôpital Privé de l'Estuaire
      • Le Kremlin-Bicêtre, France
        • CHU Bicêtre
      • Le Mans, France
        • Centre Hospitalier Du Mans
      • Lens, France
        • CH de Lens
      • Levallois-Perret, France
        • Institut Hospitalier Franco-Britannique
      • Limoges, France, 87042
        • CHU de Limoges - Hopital Dupuytren
      • Limoges, France, 87039
        • Polyclinique de Limoges - Clinique Chenieux
      • Lorient, France
        • Groupe Hospitalier Bretagne Sud - Hôpital du Scorff
      • Lyon, France
        • Centre léon Bérard
      • Lyon, France
        • Hopital Prive Jean Mermoz
      • Lyon, France
        • Clinique de la Sauvegarde
      • Lyon, France, 60004
        • HCL - Hôpital de la Croix Rousse
      • Lyon, France, 69300
        • Clinique de l'infirmerie Protestante
      • Marseille, France
        • Institut Paoli Calmettes
      • Marseille, France
        • Hopital Nord
      • Marseille, France
        • APHM - Hopital de la Timone
      • Mont-de-Marsan, France, 40000
        • Centre Hospitalier Layné
      • Montbeliard, France
        • Hôpital Nord Franche Comté
      • Montpellier, France
        • Centre de Cancérologe du Grand Montpellier
      • Montpellier, France
        • CHRU de Montpellier - Hôpital Saint-Eloi
      • Montpellier, France
        • ICM - Val d'Aurelle
      • Montélimar, France
        • CH de Montelimar
      • Mougins, France, 06250
        • Centre Azuréen de Cancérologie
      • Nancy, France
        • ORACLE - Centre d'Oncologie de Gentilly
      • Nanterre, France
        • Hopital Foch
      • Nantes, France
        • Hopital Prive du Confluent
      • Neuilly-sur-Seine, France
        • Clinique Hartmann
      • Nice, France, 06000
        • Centre Antoine Lacassagne
      • Nîmes, France
        • Institut de cancerologie du Gard
      • Nîmes, France, 30029
        • Institut de Cancérologie du Gard - ONCOGARD
      • Orléans, France
        • CHR Orleans
      • Paris, France
        • Hôpital Lariboisière
      • Paris, France
        • Institut Mutualiste Montsouris
      • Paris, France
        • HEGP
      • Paris, France
        • Hôpital Bichat
      • Paris, France
        • Hôpital Cochin
      • Paris, France
        • Institut Curie
      • Paris, France, 75000
        • Hopital de la Pitie Salpetriere
      • Paris, France
        • GH Saint Joseph
      • Paris, France
        • Groupe Hospitalier Diaconesses - Croix Saint-Simon
      • Pau, France
        • CH Pau
      • Perpignan, France
        • CH Perpignan
      • Perpignan, France
        • Centre Catalan d'Oncologie
      • Pierre-Bénite, France, 69006
        • HCL - Centre Hospitalier Lyon Sud
      • Plérin, France
        • Centre CARIO-HPCA
      • Poitiers, France
        • Hôpital de la Milétrie
      • Pontoise, France
        • CH René Dubos
      • Pringy, France
        • CH Annecy Genevois
      • Périgueux, France
        • Clinique Francheville
      • Quint-Fonsegrives, France
        • Clinique de la Croix du Sud
      • Reims, France, 51100
        • Institut de Cancer Courlancy
      • Rennes, France
        • Centre Eugène Marquis
      • Romans-sur-Isère, France, 26100
        • Hôpitaux Drôme Nord - Centre Hospitalier Romans
      • Rouen, France, 76100
        • Clinique Mathilde
      • Rouen, France
        • Centre Frédéric JOLIOT
      • Rouen, France, 76000
        • Centre Henri Becquerel
      • Saint Brieuc, France
        • Centre Hospitalier Yves Le Foll
      • Saint Gregoire, France
        • Centre Hospitalier Privé Saint Grégoire
      • Saint Nazaire, France
        • Clinique Mutualiste de l'Estuaire
      • Saint-Cloud, France, 92210
        • Institut Curie - Site Saint Cloud
      • Saint-Herblain, France
        • Institut de Cancérologie de l'Ouest - ICO
      • Saint-Malo, France
        • CH Broussais
      • Saint-Mandé, France
        • Hia Begin
      • Saint-Priest-en-Jarez, France
        • CHU Saint-Etienne - Pôle de Cancérologie
      • Saint-Étienne, France, 42100
        • Hôpital Privé de La Loire Saint-Etienne
      • Sainte-Feyre, France, 23000
        • Centre Médicale Sainte Feyre Alfred Leune
      • Sainte-Foy-lès-Lyon, France
        • Clinique Charcot
      • Sarcelles, France
        • Institut de Cancérologie Paris Nord
      • Sens, France
        • CH Sens
      • Strasbourg, France, 67037
        • ICANS - Institut de cancérologie Strasbourg Europe
      • Thionville, France, 45001
        • CHR Metz-Thionville / Hôpital de Mercy
      • Thonon-les-Bains, France
        • Hôpitaux du Léman
      • Toulon, France, 83800
        • Hôpital d'instruction des Armées Saint-Anne
      • Toulouse, France
        • Institut Claudius Regaud
      • Toulouse, France
        • Clinique Pasteur - Groupe Oncorad Garonne
      • Toulouse, France
        • Clinique Pasteur - Oncosud
      • Tours, France
        • CHU Bretonneau
      • Troyes, France
        • Centre Hospitalier de Troyes
      • Valenciennes, France
        • CH Jean Bernard
      • Valenciennes, France
        • Clinique des dentellières
      • Vandœuvre-lès-Nancy, France
        • Institut de Cancérologie de Lorraine (ICL) - Centre Alexis Vautrin
      • Villejuif, France
        • Gustave Roussy
      • Évry, France, 91000
        • Clinique du Mousseau (CMCO) - Ramsay Santé

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with ovarian and/or primitive peritoneal and/or fallopian tubes carcinoma, histologically confirmed, with an advanced stage at diagnosis (stage III to IV FIGO 2014)

Description

Inclusion Criteria:

  • Patient older than 18 years.
  • Patient with ovarian and/or primitive peritoneal and/or fallopian tubes carcinoma, histologically confirmed, with an advanced stage at diagnosis (stage III to IV FIGO 2014)
  • Patient in first line therapy

  • Available tumor sample fixed in formalin and included in paraffin (FFPE):

    • in pre-chemotherapy, insofar as possible
    • having a sufficient tumor surface, with a final cellularity of at least 20%
  • Identification of a molecular genetics' cancer platform participant in GREAT and an onco-geneticists team working with the investigator team
  • Patient consenting her data to be collected and submitted through an automated processing
  • Patient beneficiary from the French social security

Exclusion Criteria:

  • Patient with a mucinous ovarian carcinoma
  • Patient pregnant or breastfeeding
  • Patient under legal protection (guardianship or court order) or unable to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between Progression Free Survival (PFS) and the detected tumor genetic abnormalities
Time Frame: From baseline until the date of progression or death, which ever occurs earlier, assessed up to 10 years
From baseline until the date of progression or death, which ever occurs earlier, assessed up to 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between age and the detected tumor genetic abnormalities
Time Frame: Baseline
Baseline
Correlation between histology status and the detected tumor genetic abnormalities
Time Frame: Baseline
Baseline
Correlation between FIGO stage and the detected tumor genetic abnormalities
Time Frame: Baseline
Baseline
Correlation between surgery resection status and the detected tumor genetic abnormalities
Time Frame: Up to 10 years
Up to 10 years
Correlation between treatment response and the detected tumor genetic abnormalities
Time Frame: Up to 10 years
Up to 10 years
Correlation between Overall survival (OS) and the detected tumor genetic abnormalities
Time Frame: From baseline to death, assessed up to 10 years
From baseline to death, assessed up to 10 years

Other Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with both germinal and tumoral BRCA tests
Time Frame: Up to 10 years
Up to 10 years
Percentage of patients with a first germinal BRCA test, a first tumoral BRCA test, or simultaneous germinal and tumoral tests
Time Frame: Up to 10 years
Up to 10 years
Percentage of patients with and exploitable tumoral block for exploratory transversal researches
Time Frame: Up to 10 years
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCAGY/ GINECO GROUP

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Thibault De La Motte Rouge, MD., Centre Eugène Marquis, Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2019

Primary Completion (Actual)

November 7, 2022

Study Completion (Actual)

November 7, 2022

Study Registration Dates

First Submitted

July 18, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (Actual)

July 22, 2019

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GINECO-OV128
  • 2019-A01190-57 (Other Identifier: ANSM)
  • 19.06.45 (Other Identifier: Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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