Polygenic risk score to predict epithelial ovarian cancer risk
Official title: Evaluation of Polygenic Risk Score for Epithelial OVarian cancEr Risk Prediction and Clinical Outcomes in an Italian Population: the PROVE Study
Run by Catholic University of the Sacred Heart · NCT06935344 · Data updated 2026-11-12
This project will test whether a polygenic risk score can help predict epithelial ovarian cancer in women aged 18 and older by comparing women with a confirmed diagnosis to women without ovarian cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 1300 (estimated) |
| Sponsor | Catholic University of the Sacred Heart Academic / other |
| Locations | 1 site (Roma, Italia) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | February 2027 |
| Study ends | May 1, 2027 |
| Registry record updated | March 3, 2026 |
| Trial ID | NCT06935344 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older who either have a first-time histologically confirmed epithelial ovarian or fallopian tube cancer (cases) or have no history of ovarian cancer (controls) and who can give informed consent are ideal candidates.
✕Probably not a fit
Women with concurrent non-ovarian malignancies, those under 18, or those unwilling to consent are not eligible and would not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project uses a combined case-control and prospective cohort design at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, enrolling women ≥18 with histologically confirmed epithelial ovarian or fallopian tube cancer as cases and women without ovarian cancer as controls. Participants will complete a questionnaire on socio-demographics, lifestyle, reproductive history and medical history, and provide blood samples for BRCA1/2, PALB2, RAD51C, RAD51D testing and polygenic risk score (PRS) analysis. Researchers will compare PRS distributions between cases and controls and model whether adding PRS to clinical and lifestyle factors improves risk prediction, with PRS results available to participants on request and pathogenic BRCA findings referred to genetic services. Recruitment is planned over 12 months and women with concurrent non-ovarian malignancies will be excluded.
Why it matters
Potential benefit: If successful, the PRS approach could help identify women at higher risk of epithelial ovarian cancer so they can be monitored more closely or offered preventive options.
How similar studies have gone: Prior research has shown that polygenic risk scores can stratify ovarian cancer risk in populations, but their clinical utility for routine prediction is still emerging.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * For both cases and controls: the presence of concurrent malignancies other from OC.
Where it's running
-
Dipartimento Universitario di Scienze della Vita e Sanità Pubblica
Roma, Italia, Italy Recruiting
Study contacts
- Study coordinator: Stefania Boccia
- Email: stefania.boccia@unicatt.it
- Phone: +39 0630154396
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.