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HRD Tests for Ovarian cancER

RECRUITINGPhase 2Sponsored by Centre Francois Baclesse
Actively Recruiting
PhasePhase 2
SponsorCentre Francois Baclesse
Started2024-02-15
Est. completion2031-06
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions2

CancerOvarian Cancer

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