Ovarian CancerPhase 2HERONCT06152731
HRD Tests for Ovarian cancER
A Phase 2 study testing tests to determine HRD status in people with Ovarian Cancer, run by Centre Francois Baclesse at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- tests to determine HRD status
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 4 sitesFrance
- Study dates
- 15 Feb 2024to Jun 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Chu Amiens
Amiens
Pierrick THERET, MD
- Recruiting
Centre Francois Baclesse
Caen
François CHERIFI, MD
- Recruiting
Centre Oscar Lambret
Lille
Camille PASQUESOONE, MD
- Recruiting
Centre Henri Becquerel
Rouen
Marianne LEHEURTEUR, MD
About this study
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:
- Giscar assay : developed by the sponsor
- myChoice assay
If one or two tests identifies a HRD status :
a PARP inhibitor treatment may be initiated according to current recommendations
- Conditions
- Ovarian Cancer
- Being tested
- tests to determine HRD status
- Keywords
- HRD (Homologous Recombination Deficient), GIScar, myChoice, platinum chemotherapy
- Medical subject headings
- Ovarian Neoplasms, Kenny-Caffey syndrome, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| HRD tests | Other | To determine HRD status on the tumor, 2 different tests will be used concomitantly Receives: Genetic: tests to determine HRD status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: six months after the end of platinum-based chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start15 Feb 2024
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152731
- Sponsor's protocol ID
- 2023-A01585-40
- Acronym
- HERO
- Status last verified
- Sep 2025
- First submitted
- 22 Nov 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HRD Tests for Ovarian cancER
- ClinicalTrials.gov ID
- NCT06152731
- Acronym / sponsor ID
- HERO / 2023-A01585-40
- Conditions
- Ovarian Cancer
- Keywords
- HRD (Homologous Recombination Deficient), GIScar, myChoice, platinum chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Giscar assay : developed by the sponsor
- myChoice assay
If one or two tests identifies a HRD status :
a PARP inhibitor treatment may be initiated according to current recommendations
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRD tests | Other | Genetic: tests to determine HRD statusTo determine HRD status on the tumor, 2 different tests will be used concomitantly |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Patient affiliated to an appropriate social security system
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tests to determine HRD statusTest 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 | Genetic | HRD tests |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Derived from this study: PubMed 40597907Leman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tests to determine HRD status in people with Ovarian Cancer, run by Centre Francois Baclesse at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raphaël LEMAN, PhD (33231455050, r.leman@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06152731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.