Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Patient with an epithelial ovarian cancer.
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.

Primary outcomes:
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).
timeFrame: 24 months for each patient
Secondary outcomes:
measure: The rate of patients with BRCA 1/2 reversion mutations at inclusion.
timeFrame: 24 months for each patient
measure: Progression-free survival.
timeFrame: 24 months for each patient
measure: 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.
timeFrame: 24 months for each patient
measure: The rates of patients with mutations in the other genes of the HR pathway at inclusion and at relapse.
timeFrame: 24 months for each patient
Other outcomes:
Locations:
city: Angers
country: France
facility: INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Angers
city: Bordeaux
country: France
facility: Institut Bergonie
city: Limoges
country: France
facility: Chu de Limoges
city: Nimes
country: France
facility: Chu de Nimes
city: Saint-Herblain
country: France
facility: INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Saint-Herblain
city: Toulouse
country: France
facility: IUCT-O
Study officials:
References: