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
- Diseases
- Ovarian cancer
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dipartimento Universitario di Scienze della Vita e Sanità Pubblica Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.