| NCT ID | NCT06152731 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre Francois Baclesse |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2024-02-15 |
| Primary Completion | 2031-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 88 participants in total. It began in 2024-02-15 with a primary completion date of 2031-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06152731 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06152731 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06152731 currently recruiting?
Yes, NCT06152731 is actively recruiting participants. Contact the research team at r.leman@baclesse.unicancer.fr for enrollment information.
Where is the NCT06152731 trial being conducted?
This trial is being conducted at Amiens, France, Caen, France, Lille, France, Rouen, France.
Who is sponsoring the NCT06152731 clinical trial?
NCT06152731 is sponsored by Centre Francois Baclesse. The trial plans to enroll 88 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.