NCT06152731

Brief 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. 1.Giscar assay : developed by the sponsor
  2. 2.myChoice assay

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2 ovarian-cancer

Timeline
61mo left

Started Feb 2024

Longer than P75 for phase_2 ovarian-cancer

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Feb 2024Jun 2031

First Submitted

Initial submission to the registry

November 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

7.3 years

First QC Date

November 22, 2023

Last Update Submit

September 16, 2025

Conditions

Ovarian Cancer

Keywords

HRD (Homologous Recombination Deficient)GIScarmyChoiceplatinum chemotherapy

Outcome Measures

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)

    six months after the end of platinum-based chemotherapy

Study Arms (1)

HRD tests

OTHER

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

Genetic: tests to determine HRD status

Interventions

tests to determine HRD statusGENETIC

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

HRD tests

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chu Amiens

Amiens, France

NOT YET RECRUITING

Centre Francois Baclesse

Caen, France

RECRUITING

Centre Oscar Lambret

Lille, France

RECRUITING

Centre Henri Becquerel

Rouen, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40597907DERIVED

MeSH Terms

Conditions

Ovarian NeoplasmsKenny-Caffey syndrome, Type 1

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Raphaël LEMAN, PhD

CONTACT

33231455050r.leman@baclesse.unicancer.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2023

First Posted

December 1, 2023

Study Start

February 15, 2024

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

June 1, 2031

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)