PREDICTION OF GERMLINE BRCA 1/2 GENES FROM HEALTHY OVARIES

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Mar 3, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on improving the way we predict whether women carry certain genetic mutations (specifically in the BRCA1 or BRCA2 genes) that could increase their risk of developing ovarian cancer. Researchers are using ultrasound images of healthy ovaries to develop a new model that can help identify these mutations even before any symptoms appear. The study is being conducted in two parts: first, they will analyze existing images and then they will collect new images from different centers to refine their predictions.

To be eligible for this trial, women must have test results for the BRCA1 or BRCA2 genes and have had a specific type of ultrasound (transvaginal pelvic ultrasound) showing at least one healthy ovary. Participants cannot have any personal history of ovarian cancer or other significant ovarian issues, and they must be willing to provide consent for the study. If you join the trial, you'll help researchers validate this new method, which could lead to better risk assessments for ovarian cancer in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Availability of gBRCA1/2 test results
• • Transvaginal pelvic US performed providing at least one picture of one healthy ovary
• • US images stored in .dicom format.
• Exclusion Criteria:
• • Personal diagnosis of OC
• • Ovarian abnormal findings (eg. ovarian endometriomas, dermoid cyst, ovarian cystoadenofibroma, ovarian borderline tumour...) with the exception of functional cysts at pelvic US
• • gBRCA1/2 testing results nor provided by an ISO 1589 accredited laboratory
• • Refusal to provide written informed consent