Clinical trial · Interventional
HRD Tests for Ovarian cancER
NCT06152731CI-TRIAL-00095287HEROrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tests to determine HRD status | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- HRD tests
- description
- To determine HRD status on the tumor, 2 different tests will be used concomitantly
- interventionNames
- Genetic: tests to determine HRD status
Primary outcomes (1)
- measure
- Rate of platinum-sensitive ovarian cancer patients according to GIScar HRD signature (classified into HRD or HRP).
- timeFrame
- six months after the end of platinum-based chemotherapy
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLeman 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 phase II study (HERO). BMC Cancer. 2025 Jul 1;25(1):1075. doi: 10.1186/s12885-025-14423-2. PMID 40597907