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

NCT06588322 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-11-18

No results posted yet for this 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.

Conditions

Interventions

OTHER

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

* Inclusion visit (T0): prior to initiation of Olaparib treatment * Follow-up period (T1 to T8): every 3 months for a maximum of 24 months * End of study (Tx): on definitive cessation of Olaparib treatment for any reason (progression, toxicity or definitive cessation of treatment after 2 years).

Sponsors & Collaborators

  • Institut Claudius Regaud

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-08
Primary Completion
2029-11-30
Completion
2029-11-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06588322 on ClinicalTrials.gov