HRD Tests for Ovarian cancER (HERO)

September 16, 2025 updated by: Centre Francois Baclesse

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France
        • Not yet recruiting
        • CHU Amiens
        • Contact:
          • Pierrick THERET, MD
      • Caen, France
        • Recruiting
        • Centre François Baclesse
        • Contact:
          • François CHERIFI, MD
      • Lille, France
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
          • Camille PASQUESOONE, MD
      • Rouen, France
        • Recruiting
        • Centre Henri Becquerel
        • Contact:
          • Marianne LEHEURTEUR, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

November 22, 2023

First Posted (Actual)

December 1, 2023

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A01585-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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