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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with an epithelial ovarian cancer. | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples will be taken on several times (36 mL of blood taken at each time): | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months for each patient |
| Progression-free survival. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurence GLADIEFF | Contact | 05 31 15 51 01 | gladieff.laurence@iuct-oncopole.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Angers | Recruiting | Angers | France |
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|
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. |
| 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. | 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. | 24 months for each patient |
| Institut Bergonie | Recruiting | Bordeaux | France |
|
| Chu de Limoges | Recruiting | Limoges | France |
|
| Chu de Nimes | Recruiting | Nîmes | France |
|
| INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Saint-Herblain | Recruiting | Saint-Herblain | France |
|
| IUCT-O | Recruiting | Toulouse | France |
|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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