HRD Tests for Ovarian cancER

Ovarian Cancer Clinical Trial

— HERO  

Official title:

HRD Tests for Ovarian cancER

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06152731
• Other study ID #: 2023-A01585-40
• Status: Recruiting
• Phase: Phase 2
• Start date: February 15, 2024
• Est. completion date: June 2031

Study information

• Verified date: May 2024
• Source: Centre Francois Baclesse
• Contact: Raphaël LEMAN, PhD
• Phone: 33231455050
• Email: r.leman[@]baclesse.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: June 2031
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Chu Amiens	Amiens
France	Centre Francois Baclesse	Caen
France	Centre Oscar Lambret	Lille
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	six months after the end of platinum-based chemotherapy