Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
88 participants
INTERVENTIONAL
2024-02-15
2031-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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HRD tests
To determine HRD status on the tumor, 2 different tests will be used concomitantly
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Centre Francois Baclesse
OTHER
Responsible Party
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Locations
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Chu Amiens
Amiens, , France
Centre Francois Baclesse
Caen, , France
Centre Oscar Lambret
Lille, , France
Centre Henri Becquerel
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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Pierrick THERET, MD
Role: primary
François CHERIFI, MD
Role: primary
Camille PASQUESOONE, MD
Role: primary
Marianne LEHEURTEUR, MD
Role: primary
References
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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.
Other Identifiers
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2023-A01585-40
Identifier Type: -
Identifier Source: org_study_id
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