Detection of Homologous Recombination Pathway Gene Mutations in Circulating Tumour DNA From BRCA-mutated Ovarian Cancer Patients Receiving First-line PARP Inhibitor Maintenance Therapy
NCT ID: NCT06588322
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2025-01-08
2029-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patient with an epithelial ovarian cancer.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Institut Claudius Regaud
OTHER
Responsible Party
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Locations
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INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Angers
Angers, , France
Institut Bergonie
Bordeaux, , France
Chu de Limoges
Limoges, , France
Chu de Nimes
Nîmes, , France
INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Saint-Herblain
Saint-Herblain, , France
IUCT-O
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24GENF01
Identifier Type: -
Identifier Source: org_study_id
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