HRD Tests for Ovarian cancER

NCT ID: NCT06152731

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2031-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HRD tests

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

Group Type OTHER

tests to determine HRD status

Intervention Type GENETIC

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type GENETIC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Francois Baclesse

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chu Amiens

Amiens, , France

Site Status NOT_YET_RECRUITING

Centre Francois Baclesse

Caen, , France

Site Status RECRUITING

Centre Oscar Lambret

Lille, , France

Site Status RECRUITING

Centre Henri Becquerel

Rouen, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Raphaël LEMAN, PhD

Role: CONTACT

33231455050

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Pierrick THERET, MD

Role: primary

François CHERIFI, MD

Role: primary

Camille PASQUESOONE, MD

Role: primary

Marianne LEHEURTEUR, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40597907 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-A01585-40

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

[68Ga]Ga-FAPI-46 PET/CT in Ovarian Cancer
NCT05903807 RECRUITING PHASE2