HRD Tests for Ovarian cancER
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tests to determine HRD status.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Interventions
- Genetic tests 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
Primary outcome measures
- 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]
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 major impact on prognosis
- Exclusive palliative setting
- Patient deprived of liberty or placed under the authority of a tutor
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 4 centers
- Chu Amiens — Amiens
- Centre Francois Baclesse — Caen
- Centre Oscar Lambret — Lille
- Centre Henri Becquerel — Rouen
Publications
- Leman R, Cherifi F, Leheurteur M, Theret P, Pasquesoone C, Saint-Ghislain M, Bresson L, Denoyelle C, Vigneron N, Poulain L, Delepee R, Berby B, Dremaux J, Dumont A, Blanc-Fournier C, Jeanne C, Briand M, Rousseau N, Pepin LF, Deruche E, Dumont F, Leconte A, Lequesne J, Clarisse B, Joly F, Castera L, Rouzier R. Homologous recombination deficiency (HRD) tests for ovarian cancer: a multicenter French PMID 40597907
Identifiers
NCT: NCT06152731 · 2023-A01585-40