NCT06935344 Evaluation of Polygenic Risk Score for Epithelial OVarian cancEr Risk Prediction: the PROVE Study
| NCT ID | NCT06935344 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Catholic University of the Sacred Heart |
| Condition | Ovarian Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,300 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,300 participants in total. It began in 2025-06-01 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06935344 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06935344 currently recruiting?
Yes, NCT06935344 is actively recruiting participants. Contact the research team at stefania.boccia@unicatt.it for enrollment information.
Where is the NCT06935344 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06935344 clinical trial?
NCT06935344 is sponsored by Catholic University of the Sacred Heart. The trial plans to enroll 1,300 participants.
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