Evaluation of Polygenic Risk Score for Epithelial OVarian cancEr Risk Prediction: the PROVE Study
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Apr 16, 2025
Trial Information
Current as of September 09, 2025
Recruiting
Keywords
ClinConnect Summary
The PROVE Study is a research trial aimed at understanding how a specific genetic assessment, called a polygenic risk score (PRS), can help predict the risk of developing epithelial ovarian cancer in women over 18 years old. The study will compare women who have been diagnosed with this type of cancer to those who have no history of ovarian cancer. The main goals are to see if there is a link between higher PRS values and the likelihood of having ovarian cancer and to find out if this genetic score can improve the way we predict who might be at risk when we consider other health factors.
To participate in the study, women must either have a confirmed diagnosis of epithelial ovarian or fallopian tube cancer (these are the "cases") or have no history of ovarian cancer (the "controls"). Participants will fill out a questionnaire about their lifestyle and health habits, provide a blood sample for genetic analysis, and undergo the PRS assessment. This study is still in the planning stages and has not started recruiting participants yet. It’s important to note that women with other types of cancer will not be eligible to take part in this study.
Gender
FEMALE
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.
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, Italia, Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported