Prediction of Germline BRCA 1/2 Genes From Healthy Ovaries

Recruiting now

Conditions studied: BRCA Mutation, Ovarian Cancer, Ultrasound Therapy; Complications

In brief

The project aims at enhancing performance metrics and prospectively validating a radiogenomics model based on ovarian US images for predicting germline breast cancer susceptibility gene 1 and/or 2 (BRCA) status in women with healthy ovaries. The project is divided in two operational phases: Model development phase (ambispective) AIM 1: To define and implement a proper and fine-tuned image preprocessing pipeline on the existing dataset; AIM 2: To enlarge dataset size with new real images from different centers and apply data augmentation techniques, deep neural network models combined with the aforementioned handcrafted imaging features from radiomics analysis; Implementation and validation phase (prospective) AIM 3: To further cross-validate the predictive model on US images acquired prospectively in an observational multicenter study.

Key facts

Study ID

NCT05769517

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

6465

Starts

2023-03-20

Expected to finish

2031-03-08

Last updated by the study team

2026-04-24

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.