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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,500
- Locations
- 137
- Primary Endpoint
- Correlation between Progression Free Survival (PFS) and the detected tumor genetic abnormalities
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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 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
Outcomes
Primary Outcomes
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 Outcomes
- Correlation between treatment response and the detected tumor genetic abnormalities(Up to 10 years)
- Correlation between age and the detected tumor genetic abnormalities(Baseline)
- Correlation between surgery resection status and the detected tumor genetic abnormalities(Up to 10 years)
- Correlation between histology status and the detected tumor genetic abnormalities(Baseline)
- Correlation between FIGO stage and the detected tumor genetic abnormalities(Baseline)
- Correlation between Overall survival (OS) and the detected tumor genetic abnormalities(From baseline to death, assessed up to 10 years)