Detection of Homologous Recombination Pathway Gene Mutations in Circulating Tumour DNA From BRCA-mutated Ovarian Cancer Patients Receiving First-line PARP Inhibitor Maintenance Therapy

Plain-language summary

This study looks at detecting homologous recombination pathway gene mutations in circulating tumor DNA (ctDNA) from ovarian cancer patients who carry a BRCA1 or BRCA2 mutation and are receiving first-line maintenance therapy with the PARP inhibitor Olaparib. Blood samples are collected at several time points, and the study enrolls patients aged 18 and older with a confirmed BRCA mutation. Run by Institut Claudius Regaud, this study does not use clinical phases and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

Institut Claudius Regaud

Intervention

Blood samples will be taken on several times (36 mL of blood taken at each time):

Start date

1/8/2025

Estimated completion

11/1/2029

Countries

France

Related genes

Locations

• Angers, France
• Bordeaux, France
• Limoges, France
• Nîmes, France
• Saint-Herblain, France
• Toulouse, France

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Patient with an epithelial ovarian cancer, fallopian tube cancer or primitive of the peritoneum.
2. Patient with a BRCA 1 or 2 somatic and/or constitutional mutation previously confirmed and validated by an approved laboratory.
3. Patient due to start first-line maintenance treatment with Olaparib alone (PARP inhibitor) or in combination with bevacizumab.
4. Age ≥ 18 years at the time of signing the consent.
5. WHO ≤ 1.
6. Patient affiliated to a Social Security scheme in France.
7. Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study.

Exclusion Criteria:

1. Other cancer under treatment.
2. Olaparib treatment already initiated.
3. Indication for treatment with a PARP inhibitor other than Olaparib.
4. Any pathology contraindicating the sample collection procedures required by the study.
5. 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.
6. Subjects deprived of their liberty or under legal protection.