HRD Tests for Ovarian cancER
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 88
- Locations
- 5
- Primary Endpoint
- Rate of platinum-sensitive ovarian cancer patients according to GIScar HRD signature (classified into HRD or HRP).
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Secondary Outcomes
No secondary outcomes reported