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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
130
* 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).
INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Angers
Angers, France
RECRUITINGInstitut Bergonie
Bordeaux, France
RECRUITINGChu de Limoges
Limoges, France
RECRUITINGChu de Nimes
Nîmes, France
RECRUITINGINSTITUT DE CANCEROLOGIE DE L'OUEST - Site Saint-Herblain
Saint-Herblain, France
RECRUITINGIUCT-O
Toulouse, France
RECRUITINGThe 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.
Time frame: 24 months for each patient
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.
Time frame: 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.
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.
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.
Time frame: 24 months for each patient
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