HRD Tests for Ovarian cancER

Phase 2

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Genetic: tests to determine HRD status

• Registration Number: NCT06152731
• Lead Sponsor: Centre Francois Baclesse

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-11-22
• Study First Posted: 2023-12-01
• Study Start: 2024-02-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17
• Primary Completion: 2025-06
• Study Completion: 2031-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRD tests	tests to determine HRD status	To determine HRD status on the tumor, 2 different tests will be used concomitantly

Primary Outcome Measures

Name	Time	Method
Rate of platinum-sensitive ovarian cancer patients according to GIScar HRD signature (classified into HRD or HRP).	six months after the end of platinum-based chemotherapy	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)

Trial Locations

Locations (4)

Chu Amiens; 🇫🇷 Amiens, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Centre Francois Baclesse; 🇫🇷 Caen, France

Centre Oscar Lambret; 🇫🇷 Lille, France