Polygenic risk score to predict epithelial ovarian cancer risk
Evaluation of Polygenic Risk Score for Epithelial OVarian cancEr Risk Prediction and Clinical Outcomes in an Italian Population: the PROVE Study
Catholic University of the Sacred Heart · NCT06935344
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 |
|---|---|
| Enrollment | 1300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Catholic University of the Sacred Heart (other) |
| Locations | 1 site (Roma, Italia) |
| Trial ID | NCT06935344 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma, Italia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ovarian Cancer, polygenic risk score, ovarian cancer, case-control