Evaluation of Polygenic Risk Score for Epithelial OVarian cancEr Risk Prediction: the PROVE Study
NCT ID: NCT06935344
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1300 participants
OBSERVATIONAL
2025-06-01
2026-12-01
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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CASES: women with ovarian cancer
Patients with histologically proven epithelial ovarian and fallopian tube cancer (referred to as cases), consecutively enrolled in the Ovarian Carcinoma Complex Operative Unit of Policlinico Gemelli.
Polygenic Risk Score
For the PRS analysis, SNPs for genotyping will be selected based on the latest findings from GWAS on EOC, particularly leveraging the results, as reported by Dareng et al. (doi:10.1038/s41431-021-00987-7). The PRS will be calculated as a weighted sum of risk alleles based on the selected SNPs.
CONTROLS: Healthy women
Women with no previous or concomitant personal history of OC (referred as controls), consecutively enrolled in the Rheumatology Complex Operative Unit of Policlinico Gemelli.
Polygenic Risk Score
For the PRS analysis, SNPs for genotyping will be selected based on the latest findings from GWAS on EOC, particularly leveraging the results, as reported by Dareng et al. (doi:10.1038/s41431-021-00987-7). The PRS will be calculated as a weighted sum of risk alleles based on the selected SNPs.
Interventions
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Polygenic Risk Score
For the PRS analysis, SNPs for genotyping will be selected based on the latest findings from GWAS on EOC, particularly leveraging the results, as reported by Dareng et al. (doi:10.1038/s41431-021-00987-7). The PRS will be calculated as a weighted sum of risk alleles based on the selected SNPs.
Eligibility Criteria
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Inclusion Criteria
* For Controls women with no concomitant or past OC diagnosis.
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Boccia Stefania
Full Professor of Hygiene and Preventive Medicine
Locations
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Dipartimento Universitario di Scienze della Vita e Sanità Pubblica
Roma, Italia, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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7225
Identifier Type: -
Identifier Source: org_study_id
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