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Recruiting Phase 2 NCT06152731

HRD Tests for Ovarian cancER

Trial Parameters

Condition Ovarian Cancer
Sponsor Centre Francois Baclesse
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 88
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2024-02-15
Completion 2031-06
Interventions
tests to determine HRD status

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

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 m

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