HRD Tests for Ovarian cancER

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Chu Amiens
NOT_YET_RECRUITING
Amiens
Centre Francois Baclesse
RECRUITING
Caen
Centre Oscar Lambret
RECRUITING
Lille
Centre Henri Becquerel
RECRUITING
Rouen
Contact Information
Primary
Raphaël LEMAN, PhD
r.leman@baclesse.unicancer.fr
33231455050
Time Frame
Start Date: 2024-02-15
Estimated Completion Date: 2031-06
Participants
Target number of participants: 88
Treatments
Other: HRD tests
To determine HRD status on the tumor, 2 different tests will be used concomitantly
Related Therapeutic Areas
Sponsors
Leads: Centre Francois Baclesse

This content was sourced from clinicaltrials.gov

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