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

Recruiting now

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT06935344

Run by

Catholic University of the Sacred Heart

People needed

1300

Starts

2025-06-01

Expected to finish

2027-05-01

Last updated by the study team

2026-03-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• For cases: women with a first-time diagnosis of histologically confirmed epithelial ovarian or fallopian tube cancer.
• For Controls women with no concomitant or past OC diagnosis.

You may not qualify if…

• For both cases and controls: the presence of concurrent malignancies other from OC.

Where it is running

• Dipartimento Universitario di Scienze della Vita e Sanità Pubblica — Roma, Italia, Italy (enrolling)

Full record on ClinicalTrials.gov

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