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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Ovarian Cancer

Treatments: Genetic: Polygenic Risk Score

Study type: Observational

Funder types: Other

Identifiers

NCT06935344

7225 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,300 participants in 2 patient groups

CASES: women with ovarian cancer

Description:

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.

Treatment:

Genetic: Polygenic Risk Score

CONTROLS: Healthy women

Description:

Women with no previous or concomitant personal history of OC (referred as controls), consecutively enrolled in the Rheumatology Complex Operative Unit of Policlinico Gemelli.

Treatment:

Genetic: Polygenic Risk Score