Ovarian Cancer
Conditions
Keywords
HRD (Homologous Recombination Deficient), GIScar, myChoice, platinum chemotherapy
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: 1. Giscar assay : developed by the sponsor 2. myChoice assay If one or two tests identifies a HRD status : a PARP inhibitor treatment may be initiated according to current recommendations
Interventions
GENETICtests to determine HRD status
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
Sponsors
Centre Francois Baclesse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of platinum-sensitive ovarian cancer patients according to GIScar HRD signature (classified into HRD or HRP). | 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) |
Countries
France
Contacts
Primary ContactRaphaël LEMAN, PhD
Outcome results
None listed