HERO: HRD Tests for Ovarian cancER

Sponsor

Centre Francois Baclesse (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06152731

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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:

Giscar assay : developed by the sponsor
myChoice assay

If one or two tests identifies a HRD status :

a PARP inhibitor treatment may be initiated according to current recommendations

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Genetic: tests to determine HRD status	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

HRD Tests for Ovarian cancER

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Other: HRD tests To determine HRD status on the tumor, 2 different tests will be used concomitantly	Genetic: tests to determine HRD status Test Giscar AND test myChoice will be performed. If one or two tests identifies a HRD status : a PARP inhibitor treatment may be initiated according to current recommendations

Arm

Intervention/Treatment

Other: HRD tests

To determine HRD status on the tumor, 2 different tests will be used concomitantly

Genetic: tests to determine HRD status

Test Giscar AND test myChoice will be performed. If one or two tests identifies a HRD status : a PARP inhibitor treatment may be initiated according to current recommendations

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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