HRD Tests for Ovarian cancER
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Ovarian Cancer
- Sponsor
- Centre Francois Baclesse
- Enrollment
- 88
- Locations
- 4
- Primary Endpoint
- Rate of platinum-sensitive ovarian cancer patients according to GIScar HRD signature (classified into HRD or HRP).
- Status
- Recruiting
- Last Updated
- 7 months ago
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
Investigators
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
Outcomes
Primary Outcomes
Rate of platinum-sensitive ovarian cancer patients according to GIScar HRD signature (classified into HRD or HRP).
Time Frame: six months after the end of platinum-based chemotherapy
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)