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

NCT06588322 | Recruiting

• 1 other identifier: 24GENF01
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 6

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months for each patient

Secondary Outcomes (4)

• The rate of patients with BRCA 1/2 reversion mutations at inclusion.

  24 months for each patient

• Progression-free survival.

  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.

  24 months for each patient

• The rates of patients with mutations in the other genes of the HR pathway at inclusion and at relapse.

  24 months for each patient

Study Arms (1)

Patient with an epithelial ovarian cancer.

OTHER

Other: Blood samples will be taken on several times (36 mL of blood taken at each time):

Interventions

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).

Patient with an epithelial ovarian cancer.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (6)

INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Angers

Angers, France

RECRUITING

Institut Bergonie

Bordeaux, France

RECRUITING

Chu de Limoges

Limoges, France

RECRUITING

Chu de Nimes

Nîmes, France

RECRUITING

INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Saint-Herblain

Saint-Herblain, France

RECRUITING

IUCT-O

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Laurence GLADIEFF

CONTACT

05 31 15 51 01; gladieff.laurence@iuct-oncopole.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: January 8, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-09

Locations

FR (6)