Prediction of Germline BRCA 1/2 Genes From Healthy Ovaries

Plain-language summary

This study investigates whether the germline BRCA1/2 gene status can be predicted from ultrasound images of healthy ovaries. It enrolls people who have gBRCA1/2 test results and a transvaginal ultrasound image of at least one healthy ovary. It is a study without an assigned phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Intervention

Germinal BRCA

Start date

3/20/2023

Estimated completion

3/8/2031

Countries

Italy

Related genes

Locations

• Rome, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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