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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: gladieff.laurence@iuct-oncopole.fr
• Phone: 05 31 15 51 01

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.