Clinical trial NCT04027868: Genomic BRCA and Extensive ovArian Cancer Testing
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epithelial Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2019-07-22
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between Progression Free Survival (PFS) and the detected tumor genetic abnormalities
timeFrame: From baseline until the date of progression or death, which ever occurs earlier, assessed up to 10 years
Secondary outcomes:
measure: Correlation between age and the detected tumor genetic abnormalities
timeFrame: Baseline
measure: Correlation between histology status and the detected tumor genetic abnormalities
timeFrame: Baseline
measure: Correlation between FIGO stage and the detected tumor genetic abnormalities
timeFrame: Baseline
measure: Correlation between surgery resection status and the detected tumor genetic abnormalities
timeFrame: Up to 10 years
measure: Correlation between treatment response and the detected tumor genetic abnormalities
timeFrame: Up to 10 years
measure: Correlation between Overall survival (OS) and the detected tumor genetic abnormalities
timeFrame: From baseline to death, assessed up to 10 years
Other outcomes:
measure: Percentage of patients with both germinal and tumoral BRCA tests
timeFrame: Up to 10 years
measure: Percentage of patients with a first germinal BRCA test, a first tumoral BRCA test, or simultaneous germinal and tumoral tests
timeFrame: Up to 10 years
measure: Percentage of patients with and exploitable tumoral block for exploratory transversal researches
timeFrame: Up to 10 years
Locations:
city: Agen
country: France
facility: Centre de Radiothérapie et d'Oncologie de Moyenne Garonne (CROMG)
city: Aix-en-provence
country: France
facility: Hôpital Privé d'Aix en Provence
city: Aix-en-Provence
country: France
facility: Centre Hospitalier Général d'Aix-en-Provence
city: Amiens
country: France
facility: CHU Amiens
city: Amiens
country: France
facility: Clinique Victor PAUCHET
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest - ICO
city: Antony
country: France
facility: Hôpital Privé d'Antony - Ramsay Santé
city: Arras
country: France
facility: CH Arras
city: Auxerre
country: France
facility: CH Auxerre
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bayonne
country: France
facility: Clinique Belharra
city: Bayonne
country: France
facility: CH Côte Basque
city: Beauvais
country: France
facility: Centre Hospitalier de Beauvais
city: Besançon
country: France
facility: CHRU Jean Minjoz
city: Bezannes
country: France
facility: Reims Icone
city: Blois
country: France
facility: CH de Blois
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Pellegrin
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Bordeaux
country: France
facility: Institut Bergonié
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord
city: Bourg-en-Bresse
country: France
facility: Centre Hospitalier Fleyriat - BOURG-EN-BRESSE
city: Brest
country: France
facility: CHU Brest
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: Centre Maurice Tubiana
city: Cahors
country: France
facility: CH de Cahors
city: Carcassonne
country: France
facility: CH Carcassonne
city: Castres
country: France
facility: Hôpital Général de Castres
city: Challes-les-Eaux
country: France
facility: Medipole de Savoie
city: Chalon-sur-Saône
country: France
facility: CH Chalon sur Saone
city: Chambray-lès-Tours
country: France
facility: Centre d'Oncologie et de Radiothérapie 37
city: Chambéry
country: France
facility: CH Metropole Savoie
city: Cherbourg
country: France
facility: CHPC - Hôpital Louis Pasteur
city: Cholet
country: France
facility: CH Cholet
city: Châteauroux
country: France
facility: Centre Hospitalier de Chateauroux
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Contamine-sur-Arve
country: France
facility: CH Alpes Léman
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien (Site Gilles de Corbeil)
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
city: Coudekerque-Branche
country: France
facility: Clinique de Flandre
city: Creil
country: France
facility: Groupe Hospitalier public du Sud de l'Oise (GHPSO)
city: Créteil
country: France
facility: CHI Creteil
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Dijon
country: France
facility: CHU Dijon
city: Dijon
country: France
facility: Institut de Cancérologie de Bourgogne - GRReCC
city: Fréjus
country: France
facility: Centre Hospitalier Intercommunal de Fréjus Saint Raphael
city: Grenoble
country: France
facility: GH Mutualiste de Grenoble
city: Guilherand-Granges
country: France
facility: Hôpital Privé Drôme Ardèche - Clinique Pasteur
city: Jossigny
country: France
facility: Centre Hospitalier Marne-la-Vallée
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Départemental de Vendée
city: La Tronche
country: France
facility: CHU Grenoble Alpes - Site Nord (La Tronche)
city: Le Chesnay
country: France
facility: Hôpital André Mignot
city: Le Coudray
country: France
facility: Les Hôpitaux de Chartres
city: Le Havre
country: France
facility: Hôpital Privé de l'Estuaire
city: Le Kremlin-Bicêtre
country: France
facility: CHU Bicêtre
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Lens
country: France
facility: CH de Lens
city: Levallois-Perret
country: France
facility: Institut Hospitalier Franco-Britannique
city: Limoges
country: France
facility: Polyclinique de Limoges - Clinique Chenieux
city: Limoges
country: France
facility: CHU de Limoges - Hôpital Dupuytren
city: Lorient
country: France
facility: Groupe Hospitalier Bretagne Sud - Hôpital du Scorff
city: Lyon
country: France
facility: HCL - Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Clinique de l'infirmerie Protestante
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Clinique de la Sauvegarde
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
city: Marseille
country: France
facility: APHM - Hôpital de la Timone
city: Marseille
country: France
facility: Hôpital Nord
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Mont-de-Marsan
country: France
facility: Centre Hospitalier Layné
city: Montbeliard
country: France
facility: Hôpital Nord Franche Comté
city: Montpellier
country: France
facility: Centre de Cancérologe du Grand Montpellier
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital Saint-Eloi
city: Montpellier
country: France
facility: ICM - Val d'Aurelle
city: Montélimar
country: France
facility: CH de Montelimar
city: Mougins
country: France
facility: Centre Azuréen de Cancérologie
city: Nancy
country: France
facility: Oracle - Centre d'Oncologie de Gentilly
city: Nantes
country: France
facility: Hôpital Privé du Confluent
city: Neuilly-sur-Seine
country: France
facility: Clinique Hartmann
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nîmes
country: France
facility: Institut de Cancérologie du Gard - ONCOGARD
city: Nîmes
country: France
facility: Institut de Cancérologie du Gard
city: Orléans
country: France
facility: CHR Orléans
city: Paris
country: France
facility: Hôpital de la Pitié Salpétrière
city: Paris
country: France
facility: GH Saint Joseph
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses - Croix Saint-Simon
city: Paris
country: France
facility: HEGP
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Pau
country: France
facility: CH Pau
city: Perpignan
country: France
facility: Centre Catalan d'Oncologie
city: Perpignan
country: France
facility: CH Perpignan
city: Pierre-Bénite
country: France
facility: HCL - Centre Hospitalier Lyon Sud
city: Plérin
country: France
facility: Centre CARIO-HPCA
city: Poitiers
country: France
facility: Hôpital de la Milétrie
city: Pontoise
country: France
facility: CH René Dubos
city: Pringy
country: France
facility: CH Annecy Genevois
city: Périgueux
country: France
facility: Clinique Francheville
city: Quint-Fonsegrives
country: France
facility: Clinique de la Croix du Sud
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Romans-sur-Isère
country: France
facility: Hôpitaux Drôme Nord - Centre Hospitalier Romans
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Rouen
country: France
facility: Clinique Mathilde
city: Rouen
country: France
facility: Centre Frédéric Joliot
city: Saint Brieuc
country: France
facility: Centre Hospitalier Yves Le Foll
city: Saint Gregoire
country: France
facility: Centre Hospitalier Privé Saint Grégoire
city: Saint Nazaire
country: France
facility: Clinique Mutualiste de l'Estuaire
city: Saint-Cloud
country: France
facility: Institut Curie - Site Saint Cloud
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest - ICO
city: Saint-Malo
country: France
facility: CH Broussais
city: Saint-Mandé
country: France
facility: HIA Begin
city: Saint-Priest-en-Jarez
country: France
facility: CHU Saint-Etienne - Pôle de Cancérologie
city: Saint-Étienne
country: France
facility: Hôpital Privé de La Loire Saint-Etienne
city: Sainte-Feyre
country: France
facility: Centre Médicale Sainte Feyre Alfred Leune
city: Sainte-Foy-lès-Lyon
country: France
facility: Clinique Charcot
city: Sarcelles
country: France
facility: Institut de Cancérologie Paris Nord
city: Sens
country: France
facility: CH Sens
city: Strasbourg
country: France
facility: ICANS - Institut de cancérologie Strasbourg Europe
city: Suresnes
country: France
facility: Hôpital Foch
city: Thionville
country: France
facility: CHR Metz-Thionville / Hôpital de Mercy
city: Thonon-les-Bains
country: France
facility: Hôpitaux du Léman
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées Saint-Anne
city: Toulouse
country: France
facility: Clinique Pasteur - Groupe Oncorad Garonne
city: Toulouse
country: France
facility: Clinique Pasteur - Oncosud
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Tours
country: France
facility: CHU Bretonneau
city: Troyes
country: France
facility: Centre Hospitalier de Troyes
city: Valenciennes
country: France
facility: CH Jean Bernard
city: Valenciennes
country: France
facility: Clinique des Dentellières
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine (ICL) - Centre Alexis Vautrin
city: Villejuif
country: France
facility: Gustave Roussy
city: Évry
country: France
facility: Clinique du Mousseau (CMCO) - Ramsay Santé
Study officials:
affiliation: Centre Eugène Marquis, Rennes
name: Thibault De La Motte Rouge, MD.
role: PRINCIPAL_INVESTIGATOR
References: