Status:
RECRUITING
Detection of Homologous Recombination Pathway Gene Mutations in Circulating Tumour DNA From BRCA-mutated Ovarian Cancer Patients Receiving First-line PARP Inhibitor Maintenance Therapy
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is an interventional (category 2), prospective, multicentric cohort study designed to demonstrate that the search, based on Circulating tumour DNA analysis, for a BRCA1/2 reversion mutation leadi...
Eligibility Criteria
Inclusion
- Patient with an epithelial ovarian cancer, fallopian tube cancer or primitive of the peritoneum.
- Patient with a BRCA 1 or 2 somatic and/or constitutional mutation previously confirmed and validated by an approved laboratory.
- Patient due to start first-line maintenance treatment with Olaparib alone (PARP inhibitor) or in combination with bevacizumab.
- Age ≥ 18 years at the time of signing the consent.
- WHO ≤ 1.
- Patient affiliated to a Social Security scheme in France.
- Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study.
Exclusion
- Other cancer under treatment.
- Olaparib treatment already initiated.
- Indication for treatment with a PARP inhibitor other than Olaparib.
- Any pathology contraindicating the sample collection procedures required by the study.
- Any psychological, family, geographical or sociological condition that makes it impossible to comply with medical monitoring and/or the procedures laid down in the study protocol.
- Subjects deprived of their liberty or under legal protection.
Key Trial Info
Start Date :
January 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06588322
Start Date
January 8 2025
End Date
November 1 2029
Last Update
November 18 2025
Active Locations (6)
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1
INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Angers
Angers, France
2
Institut Bergonie
Bordeaux, France
3
Chu de Limoges
Limoges, France
4
Chu de Nimes
Nîmes, France