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

Обзор

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.

Вмешательства

• Другое 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).

Первичные конечные точки

• 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). [Срок оценки: 24 months for each patient]

Вторичные конечные точки (4)

• The rate of patients with BRCA 1/2 reversion mutations at inclusion. [Срок оценки: 24 months for each patient]
• Progression-free survival. [Срок оценки: 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. [Срок оценки: 24 months for each patient]
• The rates of patients with mutations in the other genes of the HR pathway at inclusion and at relapse. [Срок оценки: 24 months for each patient]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 6 центров

• INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Angers — Angers
• Institut Bergonie — Bordeaux
• Chu de Limoges — Limoges
• Chu de Nimes — Nîmes
• INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Saint-Herblain — Saint-Herblain
• IUCT-O — Toulouse

Идентификаторы

NCT: NCT06588322 · 24GENF01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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