Evaluation of Polygenic Risk Score for Epithelial OVarian cancEr Risk Prediction and Clinical Outcomes in an Italian Population: the PROVE Study

Status: Recruiting
Location: See location...
Intervention Type: Genetic
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Italy
Dipartimento Universitario di Scienze della Vita e Sanità Pubblica
RECRUITING
Roma
Contact Information
Primary
Stefania Boccia
stefania.boccia@policlinicogemelli.it
+39 0630154396
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 1300
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov

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