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

Not yet recruiting

• Conditions: Ovarian Cancer

• Registration Number: NCT06935344
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Study Start: 2025-05-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Odds of developing EOC by different PRS percentiles	At enrollment	Correlation between PRS percentiles and EOC risk

Secondary Outcome Measures

Name	Time	Method
Correlation of PRS percentiles and covariates	At enrollment	Correlation between PRS percentiles and: age, familiarity with OC, stage, histotype, grading (1-2 versus 3), BRCA1-2, PALB2, RAD51C, RAD51D, FANCM status, type of surgery, residual tumor (RT) at histology, type of chemotherapy, maintenance, chemo-resistance, response to treatment, recurrences, progressions, cancer-specific deaths, Disease Free survival (DFS) hazard ratio (HR), Overall Survival (OS) HR.

Trial Locations

Locations (1)

Dipartimento Universitario di Scienze della Vita e Sanità Pubblica; 🇮🇹 Roma, Italia, Italy