Fallopian Tube Cancer Clinical Trial
— GREATOfficial 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
| Verified date | May 2024 |
| Source | ARCAGY/ GINECO GROUP |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 1500 |
| Est. completion date | November 7, 2022 |
| Est. primary completion date | November 7, 2022 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre de Radiothérapie et d'Oncologie de Moyenne Garonne (CROMG) | Agen | |
| France | Centre Hospitalier Général d'Aix-en-Provence | Aix-en-Provence | |
| France | Hôpital Privé d'Aix en Provence | Aix-en-provence | |
| France | CHU Amiens | Amiens | |
| France | Clinique Victor PAUCHET | Amiens | |
| France | Institut de Cancérologie de l'Ouest - ICO | Angers | |
| France | Hôpital Privé d'Antony - Ramsay Santé | Antony | |
| France | CH Arras | Arras | |
| France | CH Auxerre | Auxerre | |
| France | Institut Sainte Catherine | Avignon | |
| France | CH Côte Basque | Bayonne | |
| France | Clinique Belharra | Bayonne | |
| France | Centre Hospitalier de Beauvais | Beauvais | |
| France | CHRU Jean Minjoz | Besançon | |
| France | Reims Icone | Bezannes | |
| France | CH de Blois | Blois | |
| France | Hôpital Avicenne | Bobigny | |
| France | CHU de Bordeaux - Hôpital Pellegrin | Bordeaux | |
| France | Clinique Tivoli | Bordeaux | |
| France | Institut Bergonié | Bordeaux | |
| France | Polyclinique Bordeaux Nord | Bordeaux | |
| France | Centre Hospitalier Fleyriat - BOURG-EN-BRESSE | Bourg-en-Bresse | |
| France | CHU Brest | Brest | |
| France | Hôpital Femme Mère Enfant | Bron | |
| France | Centre François Baclesse | Caen | |
| France | Centre Maurice Tubiana | Caen | |
| France | CH de Cahors | Cahors | |
| France | CH Carcassonne | Carcassonne | |
| France | Hôpital Général de Castres | Castres | |
| France | Medipole de Savoie | Challes-les-Eaux | |
| France | CH Chalon sur Saone | Chalon-sur-Saône | |
| France | CH Metropole Savoie | Chambéry | |
| France | Centre d'Oncologie et de Radiothérapie 37 | Chambray-lès-Tours | |
| France | Centre Hospitalier de Chateauroux | Châteauroux | |
| France | CHPC - Hôpital Louis Pasteur | Cherbourg | |
| France | CH Cholet | Cholet | |
| France | Hôpital Antoine Béclère | Clamart | |
| France | Centre Jean Perrin | Clermont-Ferrand | |
| France | CH Alpes Léman | Contamine-sur-Arve | |
| France | Centre Hospitalier Sud Francilien (Site Gilles de Corbeil) | Corbeil-Essonnes | |
| France | Clinique des Cèdres | Cornebarrieu | |
| France | Clinique de Flandre | Coudekerque-Branche | |
| France | Groupe Hospitalier public du Sud de l'Oise (GHPSO) | Creil | |
| France | CHI Creteil | Créteil | |
| France | Centre Georges François Leclerc | Dijon | |
| France | CHU Dijon | Dijon | |
| France | Institut de Cancérologie de Bourgogne - GRReCC | Dijon | |
| France | Clinique du Mousseau (CMCO) - Ramsay Santé | Évry | |
| France | Centre Hospitalier Intercommunal de Fréjus Saint Raphael | Fréjus | |
| France | GH Mutualiste de Grenoble | Grenoble | |
| France | Hôpital Privé Drôme Ardèche - Clinique Pasteur | Guilherand-Granges | |
| France | Centre Hospitalier Marne-la-Vallée | Jossigny | |
| France | Centre Hospitalier Départemental de Vendée | La Roche-sur-Yon | |
| France | CHU Grenoble Alpes - Site Nord (La Tronche) | La Tronche | |
| France | Hôpital André Mignot | Le Chesnay | |
| France | Les Hôpitaux de Chartres | Le Coudray | |
| France | Hôpital Privé de l'Estuaire | Le Havre | |
| France | CHU Bicêtre | Le Kremlin-Bicêtre | |
| France | Centre Hospitalier du Mans | Le Mans | |
| France | CH de Lens | Lens | |
| France | Institut Hospitalier Franco-Britannique | Levallois-Perret | |
| France | CHU de Limoges - Hôpital Dupuytren | Limoges | |
| France | Polyclinique de Limoges - Clinique Chenieux | Limoges | |
| France | Groupe Hospitalier Bretagne Sud - Hôpital du Scorff | Lorient | |
| France | Centre Léon Bérard | Lyon | |
| France | Clinique de l'infirmerie Protestante | Lyon | |
| France | Clinique de la Sauvegarde | Lyon | |
| France | HCL - Hôpital de la Croix Rousse | Lyon | |
| France | Hôpital Privé Jean Mermoz | Lyon | |
| France | APHM - Hôpital de la Timone | Marseille | |
| France | Hôpital Nord | Marseille | |
| France | Institut Paoli Calmettes | Marseille | |
| France | Centre Hospitalier Layné | Mont-de-Marsan | |
| France | Hôpital Nord Franche Comté | Montbeliard | |
| France | CH de Montelimar | Montélimar | |
| France | Centre de Cancérologe du Grand Montpellier | Montpellier | |
| France | CHRU de Montpellier - Hôpital Saint-Eloi | Montpellier | |
| France | ICM - Val d'Aurelle | Montpellier | |
| France | Centre Azuréen de Cancérologie | Mougins | |
| France | Oracle - Centre d'Oncologie de Gentilly | Nancy | |
| France | Hôpital Privé du Confluent | Nantes | |
| France | Clinique Hartmann | Neuilly-sur-Seine | |
| France | Centre Antoine Lacassagne | Nice | |
| France | Institut de Cancérologie du Gard | Nîmes | |
| France | Institut de Cancérologie du Gard - ONCOGARD | Nîmes | |
| France | CHR Orléans | Orléans | |
| France | GH Saint Joseph | Paris | |
| France | Groupe Hospitalier Diaconesses - Croix Saint-Simon | Paris | |
| France | HEGP | Paris | |
| France | Hôpital Bichat | Paris | |
| France | Hôpital Cochin | Paris | |
| France | Hôpital de la Pitié Salpétrière | Paris | |
| France | Hôpital Lariboisière | Paris | |
| France | Institut Curie | Paris | |
| France | Institut Mutualiste Montsouris | Paris | |
| France | CH Pau | Pau | |
| France | Clinique Francheville | Périgueux | |
| France | Centre Catalan d'Oncologie | Perpignan | |
| France | CH Perpignan | Perpignan | |
| France | HCL - Centre Hospitalier Lyon Sud | Pierre-Bénite | |
| France | Centre CARIO-HPCA | Plérin | |
| France | Hôpital de la Milétrie | Poitiers | |
| France | CH René Dubos | Pontoise | |
| France | CH Annecy Genevois | Pringy | |
| France | Clinique de la Croix du Sud | Quint-Fonsegrives | |
| France | Centre Eugène Marquis | Rennes | |
| France | Hôpitaux Drôme Nord - Centre Hospitalier Romans | Romans-sur-Isère | |
| France | Centre Frédéric Joliot | Rouen | |
| France | Centre Henri Becquerel | Rouen | |
| France | Clinique Mathilde | Rouen | |
| France | Centre Hospitalier Yves Le Foll | Saint Brieuc | |
| France | Centre Hospitalier Privé Saint Grégoire | Saint Gregoire | |
| France | Clinique Mutualiste de l'Estuaire | Saint Nazaire | |
| France | Institut Curie - Site Saint Cloud | Saint-Cloud | |
| France | Hôpital Privé de La Loire Saint-Etienne | Saint-Étienne | |
| France | Institut de Cancérologie de l'Ouest - ICO | Saint-Herblain | |
| France | CH Broussais | Saint-Malo | |
| France | HIA Begin | Saint-Mandé | |
| France | CHU Saint-Etienne - Pôle de Cancérologie | Saint-Priest-en-Jarez | |
| France | Centre Médicale Sainte Feyre Alfred Leune | Sainte-Feyre | |
| France | Clinique Charcot | Sainte-Foy-lès-Lyon | |
| France | Institut de Cancérologie Paris Nord | Sarcelles | |
| France | CH Sens | Sens | |
| France | ICANS - Institut de cancérologie Strasbourg Europe | Strasbourg | |
| France | Hôpital Foch | Suresnes | |
| France | CHR Metz-Thionville / Hôpital de Mercy | Thionville | |
| France | Hôpitaux du Léman | Thonon-les-Bains | |
| France | Hôpital d'Instruction des Armées Saint-Anne | Toulon | |
| France | Clinique Pasteur - Groupe Oncorad Garonne | Toulouse | |
| France | Clinique Pasteur - Oncosud | Toulouse | |
| France | Institut Claudius Regaud | Toulouse | |
| France | CHU Bretonneau | Tours | |
| France | Centre Hospitalier de Troyes | Troyes | |
| France | CH Jean Bernard | Valenciennes | |
| France | Clinique des Dentellières | Valenciennes | |
| France | Institut de Cancérologie de Lorraine (ICL) - Centre Alexis Vautrin | Vandœuvre-lès-Nancy | |
| France | Gustave Roussy | Villejuif |
| Lead Sponsor | Collaborator |
|---|---|
| ARCAGY/ GINECO GROUP | AstraZeneca |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Percentage of patients with both germinal and tumoral BRCA tests | Up to 10 years | ||
| Other | Percentage of patients with a first germinal BRCA test, a first tumoral BRCA test, or simultaneous germinal and tumoral tests | Up to 10 years | ||
| Other | Percentage of patients with and exploitable tumoral block for exploratory transversal researches | Up to 10 years | ||
| Primary | Correlation between Progression Free Survival (PFS) and the detected tumor genetic abnormalities | From baseline until the date of progression or death, which ever occurs earlier, assessed up to 10 years | ||
| Secondary | Correlation between age and the detected tumor genetic abnormalities | Baseline | ||
| Secondary | Correlation between histology status and the detected tumor genetic abnormalities | Baseline | ||
| Secondary | Correlation between FIGO stage and the detected tumor genetic abnormalities | Baseline | ||
| Secondary | Correlation between surgery resection status and the detected tumor genetic abnormalities | Up to 10 years | ||
| Secondary | Correlation between treatment response and the detected tumor genetic abnormalities | Up to 10 years | ||
| Secondary | Correlation between Overall survival (OS) and the detected tumor genetic abnormalities | From baseline to death, assessed up to 10 years |
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