Testing for HRD in ovarian cancer patients
HRD Tests for Ovarian cancER
This study is testing two different tests to see if they can identify a specific condition in women with advanced ovarian cancer so that they can get the best treatment possible.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Francois Baclesse Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Amiens and 3 other locations) |
| Trial ID | NCT06152731 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with invasive epithelial ovarian cancer who are candidates for first-line platinum-based chemotherapy. It aims to determine the homologous recombination deficiency (HRD) status using two tests: the Giscar assay and the myChoice assay. If HRD status is identified, patients may receive PARP inhibitor treatment based on current recommendations. The study seeks to improve treatment outcomes for newly diagnosed advanced ovarian cancer patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed advanced high-grade serous epithelial ovarian cancer.
Not a fit: Patients with recurrent ovarian cancer or non-epithelial types of ovarian cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with ovarian cancer.
How similar studies have performed: Other studies have shown promise in using HRD testing to guide treatment decisions in ovarian cancer, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amiens and 3 other locations
- Chu Amiens — Amiens, France (Not_yet_recruiting)
- Centre Francois Baclesse — Caen, France (Recruiting)
- Centre Oscar Lambret — Lille, France (Recruiting)
- Centre Henri Becquerel — Rouen, France (Recruiting)
Study contacts
- Study coordinator: Raphaël LEMAN, PhD
- Email: r.leman@baclesse.unicancer.fr
- Phone: 33231455050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.