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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

Study acronym: ATROVA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria expanded, about 8 wordsv7
  2. Site details revised at 4 of 6 sitesv6
  3. Site details revised at 1 of 6 sitesv5
  4. Start date changed from estimate of Dec 2024 to Jan 8, 2025
    • Site details revised at 1 of 6 sites
    v4
  5. Start date: Oct 2024 to Dec 2024
    • Primary and study completion dates: Oct 2029 to Nov 2029
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 6 of 6 sites
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06588322
Lead Sponsor Institut Claudius Regaud
Conditions
(from sponsor)		 Ovarian Cancer
Related terms Ovarian Neoplasms
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov