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HRD Tests for Ovarian cancER

HRD Tests for Ovarian cancER

Recruiting
18 years and older
Female
Phase 2

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Overview

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

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

Study details
    Ovarian Cancer

NCT06152731

Centre Francois Baclesse

26 May 2024

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