NCT06588322Recruiting
Detection of Homologous Recombination Pathway Gene Mutations in Circulating Tumour DNA From BRCA-mutated Ovarian Cancer Patients Receiving First-line PARP Inhibitor Maintenance Therapy
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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 leading to restoration of its protein function enables early identification of disease progression in BRCA1/2 mutant patients treated as first-line maintenance with a PARP inhibitor (Olaparib alone or in combination with bevacizumab) for ovarian cancer. For this study, a total of 9 blood samples will be taken from patients who will undergo a full 24-month treatment regimen. Apart from the study procedure (blood sampling), all examinations carried out in this study, treatment with Olaparib (alone or combined with bevacizumab) and patient follow-up procedures will be carried out as part of routine care in accordance with the standard practices of each investigating site. 130 patients will take part in the study, and each patient will be followed for 24 months.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 5 Sept 2024
- Start date
- 8 Jan 2025
- Primary completion date
- Nov 2029
- Lead sponsor
- Institut Claudius Regaud
- Diseases
- Ovarian cancer
- NCT number
- NCT06588322
What you commit to
- Study type: Interventional
- Planned participants: 130
- From 8 Jan 2025 to the primary completion date, Nov 2029
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Indication for treatment with a PARP inhibitor other than Olaparib.
Other illness
- Other cancer under treatment.
- 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.
Other
- Olaparib treatment already initiated.
- Any pathology contraindicating the sample collection procedures required by the study.
- Subjects deprived of their liberty or under legal protection.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut de Cancérologie de l'Ouest - Site Angers Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU de Limoges Coordinator of this site? Confirm its status | Limoges | France | Recruiting |
| CHU de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
| INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Saint-Herblain Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
| IUCT-O Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.