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

Study acronym: PROVE
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS to Catholic University of the Sacred Heartv3 Show 6 more changesShow less
    • Primary completion date: Sep 2026 to Feb 2027
    • Study completion date: Dec 1, 2026 to May 1, 2027
    • Interventions: Polygenic Risk Score (Genetic) to Biopsy on normal contralateral ovary (Diagnostic Test), Full-Field Optical Coherence Tomography (FF-OCT), combined with Dynamic Cell…
    • Secondary endpoints: 1 to 3
    • Study description expanded, about 293 words
    • Collaborators expanded, about 6 words
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Dec 31, 2025 to Sep 2026
    • Start date changed from estimate of May 1, 2025 to Jun 1, 2025
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06935344
Lead Sponsor Catholic University of the Sacred Heart
Collaborators: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions
(from sponsor)		 Ovarian Cancer
Related terms Genetic Risk Score, Ovarian Neoplasms
Enrollment 1,300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov