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NCT06935344Recruiting

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

Evaluation of Polygenic Risk Score for Epithelial OVarian cancEr Risk Prediction and Clinical Outcomes in an Italian Population: the PROVE Study

Source: ClinicalTrials.gov · Last updated 3 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1300 (estimated)
First submitted
9 Apr 2025
Start date
1 Jun 2025
Primary completion date
Feb 2027
Lead sponsor
Catholic University of the Sacred Heart
NCT number
NCT06935344

What you commit to

  • Study type: Observational
  • Planned participants: 1300
  • From 1 Jun 2025 to the primary completion date, Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dipartimento Universitario di Scienze della Vita e Sanità Pubblica
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RomaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.