Clinical Trial

Evaluation of Polygenic Risk Score for Epithelial OVarian cancEr Risk Prediction: the PROVE Study

Study acronym: PROVE
Recruiting
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Summary
The goal of this observational study is to evaluate whether polygenic risk score (PRS) assessment can help predict the onset of epithelial ovarian cancer in women aged over 18, comparing those with a histologically confirmed diagnosis of epithelial ovarian or fallopian tube cancer (cases) to women with no personal history of ovarian cancer (controls). The main questions it aims to answer are: * Is there an association between PRS and the presence of epithelial ovarian cancer? * Can PRS improve the prediction of ovarian cancer risk when adjusted for other clinical factors? Researchers will compare PRS values between cases and controls to see if higher PRS percentiles are associated with an increased risk of ovarian cancer. Participants will: * Complete a questionnaire on socio-economic status, lifestyle, and dietary habits. * Undergo blood sampling, for the analysis of BRCA1-2, PALB2, RAD51C, RAD51D pathogenic variants. * Undergo PRS analysis.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-04-16; most recent amendment 2026-02-27.
Status change: Not Yet Recruiting → Recruiting 2025-08-17
Trial Details
NCT Number NCT06935344
Lead Sponsor Catholic University of the Sacred Heart
Collaborators: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Ovarian Cancer
Enrollment 1,300 participants
Start Date 2025-06-01
Primary Completion 2027-02 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-03