HRD Tests for Ovarian cancER

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

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Kenny-Caffey syndrome, Type 1 Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Chu Amiens, Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tests to determine HRD status

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

Primary outcomes

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)

Study contacts

Contact information is provided by the study sponsor or research team.

Raphaël LEMAN, PhD

CONTACT

[email protected]

33231455050

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Acronym: HERO

Important dates

Study start: 2024
Primary completion: 2031
Study completion: 2031
First posted: Dec 1, 2023
Registry last updated: Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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