Genomic BRCA and Extensive ovArian Cancer Testing

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04027868

Acronym

GREAT

Enrollment

1500

Registered

2019-07-22

Start date

2019-12-06

Completion date

2022-11-07

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORThibault De La Motte Rouge, MD.

Centre Eugène Marquis, Rennes

Outcome results