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The study concerns patients with Invasive epithelial ovarian cancer, primary Fallopian tube carcinoma, ovarian-type peritoneal carcinoma, and with an indication of a first-line platinum-based chemotherapy.
To determine HRD status, 2 separate tests will be performed in the study:
If one or two tests identifies a HRD status :
a PARP inhibitor treatment may be initiated according to current recommendations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRD tests | Other | To determine HRD status on the tumor, 2 different tests will be used concomitantly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tests to determine HRD status | Genetic | Test Giscar AND test myChoice will be performed. If one or two tests identifies a HRD status : a PARP inhibitor treatment may be initiated according to current recommendations |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of platinum-sensitive ovarian cancer patients according to GIScar HRD signature (classified into HRD or HRP). | Evaluate Platinum-sensitivity patients (defined as absence of disease progression, according to RECIST 1.1 criteria, six months after a first-line platinum-based chemotherapy) correlated with Homologous Recombination status in tumor (HRD : Homologous Recombination deficient / HRP :Homologous Recombination Proficient) | six months after the end of platinum-based chemotherapy |
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Inclusion Criteria:
Patient aged 18-year or more
Histologically documented high grade serous epithelial ovarian cancer, fallopian tube or peritoneum cancer
Newly diagnosed advanced (International Federation of Gynecology and Obstetrics [FIGO] stage III or IV) ovarian carcinoma, candidate to a first line platinum-based chemotherapy
Tumor tissue must be available for HRD analyses (FFPE tissue block) and
Patient affiliated to an appropriate social security system
Patient signed consent form before any trial related activities
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raphaël LEMAN, PhD | Contact | 33231455050 | r.leman@baclesse.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Amiens | Not yet recruiting | Amiens | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40597907 | Derived | Leman R, Cherifi F, Leheurteur M, Theret P, Pasquesoone C, Saint-Ghislain M, Bresson L, Denoyelle C, Vigneron N, Poulain L, Delepee R, Berby B, Dremaux J, Dumont A, Blanc-Fournier C, Jeanne C, Briand M, Rousseau N, Pepin LF, Deruche E, Dumont F, Leconte A, Lequesne J, Clarisse B, Joly F, Castera L, Rouzier R. Homologous recombination deficiency (HRD) tests for ovarian cancer: a multicenter French phase II study (HERO). BMC Cancer. 2025 Jul 1;25(1):1075. doi: 10.1186/s12885-025-14423-2. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| C537021 | Kenny-Caffey syndrome, Type 1 |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| Centre Francois Baclesse | Recruiting | Caen | France |
|
| Centre Oscar Lambret | Recruiting | Lille | France |
|
| Centre Henri Becquerel | Recruiting | Rouen | France |
|
| 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 |