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

November 14, 2025 updated by: Institut Claudius Regaud

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patient with an epithelial ovarian cancer.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of patients (in the population of patients with disease progression) with disease progression that was preceded by the detection of BRCA1/2 reversion mutation in circulating tumour DNA (i.e. Sensitivity).
Time Frame: 24 months for each patient
Sensitivity is defined as the ratio of the number of disease progression events in which a reversion mutation was detected early to the number of disease progression events.
24 months for each patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of patients with BRCA 1/2 reversion mutations at inclusion.
Time Frame: 24 months for each patient
It is defined as the ratio of the number of patients with BRCA 1 / 2 reversion mutations at inclusion to the total number of patients.
24 months for each patient
Progression-free survival.
Time Frame: 24 months for each patient
It is defined as the time between the date of inclusion and the date of progression or death from any cause. Patients alive without progression at the date of last news are censored.
24 months for each patient
The concordance between the type/location of the germline or somatic BRCA1/2 mutation and the BRCA1/2 reversion mutation will be presented in the form of a contingency table.
Time Frame: 24 months for each patient
24 months for each patient
The rates of patients with mutations in the other genes of the HR pathway at inclusion and at relapse.
Time Frame: 24 months for each patient
It will be defined respectively by the ratio of the number of patients with reversion mutations at inclusion to the total number of patients and by the ratio of the number of patients with reversion mutations at relapse to the total number of patients with relapse.
24 months for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2025

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

September 5, 2024

First Submitted That Met QC Criteria

September 6, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24GENF01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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