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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCatholic University of the Sacred Heart

About this trial

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

Qualifiers

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.

Disqualifiers

For both cases and controls: the presence of concurrent malignancies other from OC.

Trial design

Treatments tested in this trial

  • Polygenic Risk Score
  • Biopsy on normal contralateral ovary
  • Pharmacogenetic profiles
  • Full-Field Optical Coherence Tomography (FF-OCT), combined with Dynamic Cell Imaging (Van Gogh System) on detecting ovarian cancer lesions from tissue samples

Treatment groups

1,300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Catholic University of the Sacred Heart

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborator