Ovarian CancerATROVANCT06588322
Detection of Homologous Recombination Pathway Gene Mutations in Circulating Tumour DNA From BRCA-mutated Ovarian Cancer Patients Receiving First-line PARP Inhibitor Maintenance Therapy
A study testing Blood samples will be taken on several times (36 mL of blood taken at each time): in people with Ovarian Cancer, run by Institut Claudius Regaud at 6 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Blood samples will be taken on several times (36 mL of blood taken at each time):
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 6 sitesFrance
- Study dates
- 8 Jan 2025to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with an epithelial ovarian cancer, fallopian tube cancer or primitive of the peritoneum.
- Patient with a BRCA 1 or 2 somatic and/or constitutional mutation previously confirmed and validated by an approved laboratory.
- Patient due to start first-line maintenance treatment with Olaparib alone (PARP inhibitor) or in combination with bevacizumab.
- Age ≥ 18 years at the time of signing the consent.
- WHO ≤ 1.
- Patient affiliated to a Social Security scheme in France.
- Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study.
Who cannot join
- Other cancer under treatment.
- Olaparib treatment already initiated.
- Indication for treatment with a PARP inhibitor other than Olaparib.
- Any pathology contraindicating the sample collection procedures required by the study.
- 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.
- Subjects deprived of their liberty or under legal protection.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Angers
Angers
Jean-Sébastien FRENEL, 02 40 67 99 00, jean-sebastien.frenel@ico.unicancer.fr
- Recruiting
Institut Bergonie
Bordeaux
Coriolan LEBRETON, 05 56 33 32 79, c.lebreton@bordeaux.unicancer.fr
- Recruiting
Chu de Limoges
Limoges
Laurence VENAT, 05 55 05 63 96, laurence.venat@chu-limoges.fr
- Recruiting
Chu de Nimes
Nîmes
Frédéric FITENI, 04 66 68 33 01, frederic.fiteni@chu-nimes.fr
- Recruiting
INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Saint-Herblain
Saint-Herblain
Jean-Sébastien FRENEL, 02 40 67 99 00, jean-sebastien.frenel@ico.unicancer.fr
- Recruiting
IUCT-O
Toulouse
Laurence GLADIEFF, 05 31 15 51 01, gladieff.laurence@iuct-oncopole.fr
About this study
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.
Read more
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
- Being tested
- Blood samples will be taken on several times (36 mL of blood taken at each time):
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples will be taken on several times (36 mL of blood taken at each time):Other
- 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).
| Study group | Role | What they receive |
|---|---|---|
| Patient with an epithelial ovarian cancer. | Other | Not described Receives: Other: Blood samples will be taken on several times (36 mL of blood taken at each time): |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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.
Measured: 24 months for each patient
Secondary outcomes (4)
The rate of patients with BRCA 1/2 reversion mutations at inclusion.
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.
Measured: 24 months for each patient
Progression-free survival.
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.
Measured: 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.
Measured: 24 months for each patient
The rates of patients with mutations in the other genes of the HR pathway at inclusion and at relapse.
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.
Measured: 24 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start8 Jan 2025
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588322
- Sponsor's protocol ID
- 24GENF01
- Acronym
- ATROVA
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Homologous Recombination Pathway Gene Mutations in Circulating Tumour DNA From BRCA-mutated Ovarian Cancer Patients Receiving First-line PARP Inhibitor Maintenance Therapy
- ClinicalTrials.gov ID
- NCT06588322
- Acronym / sponsor ID
- ATROVA / 24GENF01
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with an epithelial ovarian cancer. | Other | Other: Blood samples will be taken on several times (36 mL of blood taken at each time): |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with an epithelial ovarian cancer, fallopian tube cancer or primitive of the peritoneum.
- Patient with a BRCA 1 or 2 somatic and/or constitutional mutation previously confirmed and validated by an approved laboratory.
- Patient due to start first-line maintenance treatment with Olaparib alone (PARP inhibitor) or in combination with bevacizumab.
- Age ≥ 18 years at the time of signing the consent.
- WHO ≤ 1.
Key exclusion criteria (6 listed)
- Other cancer under treatment.
- Olaparib treatment already initiated.
- Indication for treatment with a PARP inhibitor other than Olaparib.
- Any pathology contraindicating the sample collection procedures required by the study.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Patient with an epithelial ovarian cancer. |
Primary outcome
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.
4 secondary outcomes
The rate of patients with BRCA 1/2 reversion mutations at inclusion.
Time frame: 24 months for each patient
Progression-free survival.
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples will be taken on several times (36 mL of blood taken at each time): in people with Ovarian Cancer, run by Institut Claudius Regaud at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurence GLADIEFF (05 31 15 51 01, gladieff.laurence@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.