HRD Tests for Ovarian cancER

Study Overview
=================
Brief Summary
-----------------
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: Giscar assay : developed by the sponsor myChoice assay If one or two tests identifies a HRD status : a PARP inhibitor treatment may be initiated according to current recommendations

Official Title
-----------------
HRD Tests for Ovarian cancER

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Genetic: tests to determine HRD status


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Collected if possible during the initial surgery or the initial biopsy (before chemotherapy) With sufficient tumour surface area (> 25 mm²), with a final cellularity of at least 20% Patient affiliated to an appropriate social security system Patient signed consent form before any trial related activities Exclusion Criteria: Recurrent high grade serous epithelial ovarian cancer, fallopian tube or peritoneum cancer Non epithelial or borderline ovarian cancer Other tumor, for which the treatment may interfere with the ovarian cancer treatment and/or that may have a major impact on prognosis Exclusive palliative setting Patient deprived of liberty or placed under the authority of a tutor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HRD tests<br>To determine HRD status on the tumor, 2 different tests will be used concomitantly | Genetic: tests to determine HRD status<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HRD (Homologous Recombination Deficient), GIScar, myChoice, platinum chemotherapy