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RecruitingNCT06152731HEROUpdated Sep 17, 2025

HRD Tests for Ovarian cancER

A Phase 2 interventional study of tests to determine HRD status in Ovarian Cancer, sponsored by Centre Francois Baclesse. Recruiting at 4 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.

Sponsored by Centre Francois Baclesse · Phase 2, Interventional, and Diagnostic

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 7 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
88
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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

02

Conditions studied

  • Ovarian Cancer

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Keywords

  • HRD (Homologous Recombination Deficient)
  • GIScar
  • myChoice
  • platinum chemotherapy
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 88 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Centre Francois Baclesse is the lead sponsor of 109 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
88 participants (estimated)

Study arms

  • Other
    HRD tests

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

    Genetic: tests to determine HRD status

Interventions

  • Genetictests 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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

3 of 4 sites recruiting
  • Chu Amiens
    Amiens, France
    • Pierrick THERET, MD · Contact
    Not yet recruiting
  • Centre Francois Baclesse
    Caen, France
    • François CHERIFI, MD · Contact
    Recruiting
  • Centre Oscar Lambret
    Lille, France
    • Camille PASQUESOONE, MD · Contact
    Recruiting
  • Centre Henri Becquerel
    Rouen, France
    • Marianne LEHEURTEUR, MD · Contact
    Recruiting
08

References and documents

Publications

  • Leman R, Cherifi F, Leheurteur M, Theret P, Pasquesoone C, Saint-Ghislain M, Bresson L, Denoyelle C, Vigneron N, Poulain L, Delepee R, Berby B, Dremaux J, Dumont A, Blanc-Fournier C, Jeanne C, Briand M, Rousseau N, Pepin LF, Deruche E, Dumont F, Leconte A, Lequesne J, Clarisse B, Joly F, Castera L, Rouzier R. Homologous recombination deficiency (HRD) tests for ovarian cancer: a multicenter French phase II study (HERO). BMC Cancer. 2025 Jul 1;25(1):1075. doi: 10.1186/s12885-025-14423-2. PubMed 40597907 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06152731
Lead sponsor
Centre Francois Baclesse
Responsible party
Sponsor
First posted
Dec 1, 2023
Start date
Feb 15, 2024
Primary completion
Jun 2031 (estimated)
Completion
Jun 2031 (estimated)
Last update
Sep 17, 2025

Study contacts

Raphaël LEMAN, PhD
Contact
r.leman@baclesse.unicancer.fr
33231455050

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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