HRD Tests for Ovarian cancER

Phase 2RecruitingNCT06152731

Centre Francois Baclesse88 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Ovarian Cancer

Interventions

tests to determine HRD statusGENETIC

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Chu Amiens

Amiens, France

NOT_YET_RECRUITING

Centre Francois Baclesse

Caen, France

RECRUITING

Centre Oscar Lambret

Lille, France

RECRUITING

Outcomes

Primary Outcomes

Rate of platinum-sensitive ovarian cancer patients according to GIScar HRD signature (classified into HRD or HRP).

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)

Time frame: six months after the end of platinum-based chemotherapy

Central Contacts

Raphaël LEMAN, PhD

CONTACT

33231455050 r.leman@baclesse.unicancer.fr

Data from ClinicalTrials.gov

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