GREAT: Genomic BRCA and Extensive ovArian Cancer Testing
Sponsor
ARCAGY/ GINECO GROUP (Other)
Overall Status
Recruiting
CT.gov ID
NCT04027868
Collaborator
AstraZeneca (Industry)
32
137
119.9
0.2
0
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
32 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date
:
Dec 6, 2019
Anticipated Primary Completion Date
:
Dec 1, 2029
Anticipated Study Completion Date
:
Dec 1, 2029
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Correlation between age and the detected tumor genetic abnormalities [Baseline]
- Correlation between histology status and the detected tumor genetic abnormalities [Baseline]
- Correlation between FIGO stage and the detected tumor genetic abnormalities [Baseline]
- Correlation between surgery resection status and the detected tumor genetic abnormalities [Up to 10 years]
- Correlation between treatment response and the detected tumor genetic abnormalities [Up to 10 years]
- Correlation between Overall survival (OS) and the detected tumor genetic abnormalities [From baseline to death, assessed up to 10 years]
Other Outcome Measures
- Percentage of patients with both germinal and tumoral BRCA tests [Up to 10 years]
- Percentage of patients with a first germinal BRCA test, a first tumoral BRCA test, or simultaneous germinal and tumoral tests [Up to 10 years]
- Percentage of patients with and exploitable tumoral block for exploratory transversal researches [Up to 10 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre de Radiothérapie et d'Oncologie de Moyenne Garonne (CROMG) | Agen | France | 47000 | |
| 2 | Hôpital Privé d'Aix en Provence | Aix-en-provence | France | 13080 | |
| 3 | Centre Hospitalier Général d'Aix-en-Provence | Aix-en-Provence | France | ||
| 4 | CHU Amiens | Amiens | France | ||
| 5 | Clinique de l'Europe | Amiens | France | ||
| 6 | Institut de Cancérologie de l'Ouest - ICO | Angers | France | ||
| 7 | Hôpital Privé d'Antony - Ramsay Santé | Antony | France | 92160 | |
| 8 | CH Arras | Arras | France | ||
| 9 | CH Auxerre | Auxerre | France | ||
| 10 | Institut Sainte Catherine | Avignon | France | ||
| 11 | Clinique Belharra | Bayonne | France | 64100 | |
| 12 | CH Côte Basque | Bayonne | France | ||
| 13 | Centre Hospitalier de Beauvais | Beauvais | France | 60021 | |
| 14 | CHRU Jean Minjoz | Besançon | France | ||
| 15 | CH de Blois | Blois | France | ||
| 16 | Hôpital Avicenne | Bobigny | France | 93009 | |
| 17 | CHU de Bordeaux - Hôpital Pellegrin | Bordeaux | France | ||
| 18 | Clinique Tivoli | Bordeaux | France | ||
| 19 | Institut Bergonié | Bordeaux | France | ||
| 20 | Polyclinique Bordeaux Nord | Bordeaux | France | ||
| 21 | CH Bourg en Bresse | Bourg-en-Bresse | France | ||
| 22 | CHU Brest | Brest | France | ||
| 23 | Hôpital Femme Mère Enfant | Bron | France | 89500 | |
| 24 | Centre François Baclesse | Caen | France | ||
| 25 | Centre Maurice Tubiana | Caen | France | ||
| 26 | CH de Cahors | Cahors | France | ||
| 27 | CH Carcassonne | Carcassonne | France | ||
| 28 | Hôpital Général de Castres | Castres | France | ||
| 29 | Medipole de Savoie | Challes-les-Eaux | France | ||
| 30 | CH Chalon sur Saone | Chalon-sur-Saône | France | ||
| 31 | Centre d'Oncologie et de Radiothérapie 37 | Chambray-lès-Tours | France | ||
| 32 | CH Metropole Savoie | Chambéry | France | ||
| 33 | CHPC - Hôpital Louis Pasteur | Cherbourg | France | ||
| 34 | CH Cholet | Cholet | France | ||
| 35 | Centre Hospitalier de Chateauroux | Châteauroux | France | 36000 | |
| 36 | Hôpital Antoine Béclère | Clamart | France | ||
| 37 | Centre Jean Perrin | Clermont-Ferrand | France | ||
| 38 | CH Alpes Léman | Contamine-sur-Arve | France | ||
| 39 | Centre Hospitalier Sud Francilien (Site Gilles de Corbeil) | Corbeil-Essonnes | France | 91106 | |
| 40 | Clinique des Cèdres | Cornebarrieu | France | 31700 | |
| 41 | Clinique de Flandre | Coudekerque-Branche | France | ||
| 42 | Groupe Hospitalier public du Sud de l'Oise (GHPSO) | Creil | France | ||
| 43 | CHI Creteil | Créteil | France | ||
| 44 | Centre Georges François Leclerc | Dijon | France | ||
| 45 | CHU Dijon | Dijon | France | ||
| 46 | Institut de Cancérologie de Bourgogne - GRReCC | Dijon | France | ||
| 47 | Centre Hospitalier Intercommunal de Fréjus Saint Raphael | Fréjus | France | 83600 | |
| 48 | GH Mutualiste de Grenoble | Grenoble | France | ||
| 49 | Hôpital Privé Drôme Ardèche - Clinique Pasteur | Guilherand-Granges | France | 07500 | |
| 50 | Centre Hospitalier Marne-la-Vallée | Jossigny | France | ||
| 51 | Centre Hospitalier Départemental de Vendée | La Roche-sur-Yon | France | 85925 | |
| 52 | CHU Grenoble Alpes - Site Nord (La Tronche) | La Tronche | France | ||
| 53 | Hôpital André Mignot | Le Chesnay | France | ||
| 54 | Les Hôpitaux de Chartres | Le Coudray | France | ||
| 55 | Hôpital Privé de l'Estuaire | Le Havre | France | 76600 | |
| 56 | CHU Bicêtre | Le Kremlin-Bicêtre | France | ||
| 57 | Centre Hospitalier du Mans | Le Mans | France | ||
| 58 | CH de Lens | Lens | France | ||
| 59 | Institut Hospitalier Franco-Britannique | Levallois-Perret | France | ||
| 60 | Polyclinique de Limoges - Clinique Chenieux | Limoges | France | 87039 | |
| 61 | CHU de Limoges - Hôpital Dupuytren | Limoges | France | 87042 | |
| 62 | Groupe Hospitalier Bretagne Sud - Hôpital du Scorff | Lorient | France | ||
| 63 | HCL - Hôpital de la Croix Rousse | Lyon | France | 60004 | |
| 64 | Clinique de l'infirmerie Protestante | Lyon | France | 69300 | |
| 65 | Centre Léon Bérard | Lyon | France | ||
| 66 | Clinique de la Sauvegarde | Lyon | France | ||
| 67 | Hôpital Privé Jean Mermoz | Lyon | France | ||
| 68 | APHM - Hôpital de la Timone | Marseille | France | ||
| 69 | Hôpital Nord | Marseille | France | ||
| 70 | Institut Paoli Calmettes | Marseille | France | ||
| 71 | Centre Hospitalier Layné | Mont-de-Marsan | France | 40000 | |
| 72 | Hôpital Nord Franche Comté | Montbeliard | France | ||
| 73 | Centre de Cancérologe du Grand Montpellier | Montpellier | France | ||
| 74 | CHRU de Montpellier - Hôpital Saint-Eloi | Montpellier | France | ||
| 75 | ICM - Val d'Aurelle | Montpellier | France | ||
| 76 | CH de Montelimar | Montélimar | France | ||
| 77 | Centre Azuréen de Cancérologie | Mougins | France | 06250 | |
| 78 | Oracle - Centre d'Oncologie de Gentilly | Nancy | France | ||
| 79 | Hôpital Foch | Nanterre | France | ||
| 80 | Hôpital Privé du Confluent | Nantes | France | ||
| 81 | Clinique Hartmann | Neuilly-sur-Seine | France | ||
| 82 | Centre Antoine Lacassagne | Nice | France | 06000 | |
| 83 | Institut de Cancérologie du Gard - ONCOGARD | Nîmes | France | 30029 | |
| 84 | Institut de Cancérologie du Gard | Nîmes | France | ||
| 85 | CHR Orléans | Orléans | France | ||
| 86 | Hôpital de la Pitié Salpétrière | Paris | France | 75000 | |
| 87 | GH Saint Joseph | Paris | France | ||
| 88 | Groupe Hospitalier Diaconesses - Croix Saint-Simon | Paris | France | ||
| 89 | HEGP | Paris | France | ||
| 90 | Hôpital Bichat | Paris | France | ||
| 91 | Hôpital Cochin | Paris | France | ||
| 92 | Hôpital Lariboisière | Paris | France | ||
| 93 | Institut Curie | Paris | France | ||
| 94 | Institut Mutualiste Montsouris | Paris | France | ||
| 95 | CH Pau | Pau | France | ||
| 96 | Centre Catalan d'Oncologie | Perpignan | France | ||
| 97 | CH Perpignan | Perpignan | France | ||
| 98 | HCL - Centre Hospitalier Lyon Sud | Pierre-Bénite | France | 69006 | |
| 99 | Centre CARIO-HPCA | Plérin | France | ||
| 100 | Hôpital de la Milétrie | Poitiers | France | ||
| 101 | CH René Dubos | Pontoise | France | ||
| 102 | CH Annecy Genevois | Pringy | France | ||
| 103 | Clinique Francheville | Périgueux | France | ||
| 104 | Clinique de la Croix du Sud | Quint-Fonsegrives | France | ||
| 105 | Institut de Cancer Courlancy | Reims | France | 51100 | |
| 106 | Centre Eugène Marquis | Rennes | France | ||
| 107 | Hôpitaux Drôme Nord - Centre Hospitalier Romans | Romans-sur-Isère | France | 26100 | |
| 108 | Centre Henri Becquerel | Rouen | France | 76000 | |
| 109 | Clinique Mathilde | Rouen | France | 76100 | |
| 110 | Centre Frédéric Joliot | Rouen | France | ||
| 111 | Centre Hospitalier Yves Le Foll | Saint Brieuc | France | ||
| 112 | Centre Hospitalier Privé Saint Grégoire | Saint Gregoire | France | ||
| 113 | Clinique Mutualiste de l'Estuaire | Saint Nazaire | France | ||
| 114 | Institut Curie - Site Saint Cloud | Saint-Cloud | France | 92210 | |
| 115 | Institut de Cancérologie de l'Ouest - ICO | Saint-Herblain | France | ||
| 116 | CH Broussais | Saint-Malo | France | ||
| 117 | HIA Begin | Saint-Mandé | France | ||
| 118 | CHU Saint-Etienne - Pôle de Cancérologie | Saint-Priest-en-Jarez | France | ||
| 119 | Hôpital Privé de La Loire Saint-Etienne | Saint-Étienne | France | 42100 | |
| 120 | Centre Médicale Sainte Feyre Alfred Leune | Sainte-Feyre | France | 23000 | |
| 121 | Clinique Charcot | Sainte-Foy-lès-Lyon | France | ||
| 122 | Institut de Cancérologie Paris Nord | Sarcelles | France | ||
| 123 | CH Sens | Sens | France | ||
| 124 | ICANS - Institut de cancérologie Strasbourg Europe | Strasbourg | France | 67037 | |
| 125 | CHR Metz-Thionville / Hôpital de Mercy | Thionville | France | 45001 | |
| 126 | Hôpitaux du Léman | Thonon-les-Bains | France | ||
| 127 | Hôpital d'Instruction des Armées Saint-Anne | Toulon | France | 83800 | |
| 128 | Clinique Pasteur - Groupe Oncorad Garonne | Toulouse | France | ||
| 129 | Clinique Pasteur - Oncosud | Toulouse | France | ||
| 130 | Institut Claudius Regaud | Toulouse | France | ||
| 131 | CHU Bretonneau | Tours | France | ||
| 132 | Centre Hospitalier de Troyes | Troyes | France | ||
| 133 | CH Jean Bernard | Valenciennes | France | ||
| 134 | Clinique des Dentellières | Valenciennes | France | ||
| 135 | Institut de Cancérologie de Lorraine (ICL) - Centre Alexis Vautrin | Vandœuvre-lès-Nancy | France | ||
| 136 | Gustave Roussy | Villejuif | France | ||
| 137 | Clinique du Mousseau (CMCO) - Ramsay Santé | Évry | France | 91000 |
Sponsors and Collaborators
- ARCAGY/ GINECO GROUP
- AstraZeneca
Investigators
- Principal Investigator: Thibault De La Motte Rouge, MD., Centre Eugène Marquis, Rennes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT04027868
Other Study ID Numbers:
- GINECO-OV128
- 2019-A01190-57
- 19.06.45
First Posted:
Jul 22, 2019
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: