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New treatment option for Ovarian Cancer
Official title Detection of Homologous Recombination Pathway Gene Mutations in Circulating Tumour DNA From BRCA-mutated Ovarian Cancer Patients Receiving First-line PARP Inhibitor Maintenance Therapy
ClinicalTrials.gov ID: NCT06588322
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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.
You likely can't join if
- 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...
- people deprived of their liberty or under legal protection.
See the full eligibility criteria
- 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.
- 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.
- people deprived of their liberty or under legal protection.
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Bordeaux, France
- Limoges, France
- Nîmes, France
- Saint-Herblain, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Bordeaux, France; Limoges, France; Nîmes, France; Saint-Herblain, France; Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.