HRD Tests for Ovarian cancER
ConditionOvarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Francois Baclesse
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
tests to determine HRD status
GeneticTest 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
Treatment groups
88 Participants
are divided into 1 treatment groupGroup A: HRD testsOther 1 intervention
Trial outcomes
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)
Time frame
six months after the end of platinum-based chemotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov