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

Last updated: April 30, 2025
Sponsor: Institut Claudius Regaud
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ovarian Cancer

Ovarian Cysts

Pelvic Cancer

Treatment

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

Clinical Study ID

NCT06588322
24GENF01
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient with an epithelial ovarian cancer.

  2. Patient with a BRCA 1 or 2 somatic and/or constitutional mutation previouslyconfirmed and validated by an approved laboratory.

  3. Patient due to start first-line maintenance treatment with Olaparib alone (PARPinhibitor) 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 toany specific procedure for the study.

Exclusion

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 thestudy.

  5. Any psychological, family, geographical or sociological condition that makes itimpossible to comply with medical monitoring and/or the procedures laid down in thestudy protocol.

  6. Subjects deprived of their liberty or under legal protection.

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: Blood samples will be taken on several times (36 mL of blood taken at each time):
Phase:
Study Start date:
January 08, 2025
Estimated Completion Date:
November 30, 2029

Connect with a study center

  • INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Angers

    Angers,
    France

    Site Not Available

  • Institut Bergonie

    Bordeaux,
    France

    Site Not Available

  • Chu de Limoges

    Limoges,
    France

    Active - Recruiting

  • Chu de Nimes

    Nimes,
    France

    Site Not Available

  • INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Saint-Herblain

    Saint-Herblain,
    France

    Site Not Available

  • IUCT-O

    Toulouse,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.