NCT06588322

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Ovarian Cancer

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-01-08
• Primary completion: 2029-11-01
• Completion: 2029-11-01
• First posted: 2024-09-19
• Last updated: 2025-11-18

Locations

6 sites across 1 country: France