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出境医 / 临床实验 / Genomic BRCA and Extensive ovArian Cancer Testing (GREAT)
Genomic BRCA and Extensive ovArian Cancer Testing (GREAT)
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 |
|---|
| Epithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer |
Study Design
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 32 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 10 Years |
| 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 : | December 6, 2019 |
| Estimated Primary Completion Date : | December 2029 |
| Estimated Study Completion Date : | December 2029 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- Correlation between age and the detected tumor genetic abnormalities [ Time Frame: Baseline ]
- Correlation between histology status and the detected tumor genetic abnormalities [ Time Frame: Baseline ]
- Correlation between FIGO stage and the detected tumor genetic abnormalities [ Time Frame: Baseline ]
- Correlation between surgery resection status and the detected tumor genetic abnormalities [ Time Frame: Up to 10 years ]
- Correlation between treatment response and the detected tumor genetic abnormalities [ Time Frame: 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 ]
Other Outcome Measures:
- Percentage of patients with both germinal and tumoral BRCA tests [ Time Frame: 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 ]
- Percentage of patients with and exploitable tumoral block for exploratory transversal researches [ Time Frame: Up to 10 years ]
Biospecimen Retention: Samples With DNA
Tumor sample fixed in formalin and included in paraffin (FFPE)
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| 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)
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
Contacts and Locations
Contacts
| Contact: Aurelie Chabanon, PhD. | +33184852036 | achabanon@arcagy.org | |
| Contact: Margaux Matos | +33184852021 ext 01 | mmatos@arcagy.org |
Locations
Show 132 study locations
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 18, 2019 | ||||||||
| First Posted Date | July 22, 2019 | ||||||||
| Last Update Posted Date | January 29, 2021 | ||||||||
| Actual Study Start Date | December 6, 2019 | ||||||||
| Estimated Primary Completion Date | December 2029 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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 ] | ||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title | 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 | ||||||||
| 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 | Not Provided | ||||||||
| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | 10 Years | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
Tumor sample fixed in formalin and included in paraffin (FFPE)
|
||||||||
| 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) | ||||||||
| Condition |
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
32 | ||||||||
| Original Estimated Enrollment |
4500 | ||||||||
| Estimated Study Completion Date | December 2029 | ||||||||
| Estimated Primary Completion Date | December 2029 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04027868 | ||||||||
| Other Study ID Numbers | GINECO-OV128 2019-A01190-57 ( Other Identifier: ANSM ) 19.06.45 ( Other Identifier: Ethics Committee ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | ARCAGY/ GINECO GROUP | ||||||||
| Study Sponsor | ARCAGY/ GINECO GROUP | ||||||||
| Collaborators | AstraZeneca | ||||||||
| Investigators |
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| PRS Account | ARCAGY/ GINECO GROUP | ||||||||
| Verification Date | May 2020 | ||||||||
