Detecting gene mutations in blood from ovarian cancer patients on PARP inhibitor therapy

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

This study is testing if checking blood for specific gene changes in ovarian cancer patients on a treatment called Olaparib can help doctors catch problems early and improve their care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Institut Claudius Regaud (Academic / other)
• Drugs / interventions: bevacizumab
• Locations: 6 sites (Angers and 5 other locations)
• Trial ID: NCT06588322 on ClinicalTrials.gov

What this trial studies

This interventional study aims to identify BRCA1/2 reversion mutations in circulating tumor DNA from patients with ovarian cancer who are receiving first-line maintenance therapy with the PARP inhibitor Olaparib, either alone or in combination with bevacizumab. A total of 130 patients will provide blood samples at multiple time points over a 24-month treatment period to monitor for disease progression. The study seeks to demonstrate that early detection of these mutations can lead to timely interventions and improved patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adult patients with epithelial ovarian cancer who have a confirmed BRCA1 or BRCA2 mutation and are about to start first-line maintenance treatment with Olaparib.

Not a fit: Patients with other active cancers, those already receiving Olaparib, or those unable to comply with study procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enable earlier identification of disease progression in ovarian cancer patients, potentially leading to more effective treatment strategies.

How similar studies have performed: While the approach of using circulating tumor DNA for mutation detection is gaining traction, this specific study's focus on BRCA reversion mutations in the context of PARP inhibitor therapy is relatively novel.

Eligibility criteria

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.

Where this trial is running

Angers and 5 other locations

• INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Angers — Angers, France (Recruiting)
• Institut Bergonie — Bordeaux, France (Recruiting)
• Chu de Limoges — Limoges, France (Recruiting)
• Chu de Nimes — Nîmes, France (Recruiting)
• INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Saint-Herblain — Saint-Herblain, France (Recruiting)
• Iuct-O — Toulouse, France (Recruiting)

Study contacts

• Study coordinator: Laurence GLADIEFF

Conditions Ovarian Cancer