Actively Recruiting
Prediction of Germline BRCA 1/2 Genes From Healthy Ovaries
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-04-24
6465
Participants Needed
1
Research Sites
415 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prediction of Germline BRCA 1/2 Genes From Healthy Ovaries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Availability of germline BRCA1/2 test results
- Transvaginal pelvic ultrasound performed providing at least one picture of one healthy ovary
- Ultrasound images stored in .dicom format
You will not qualify if you...
- Personal diagnosis of ovarian cancer
- Ovarian abnormal findings (such as ovarian endometriomas, dermoid cyst, ovarian cystoadenofibroma, ovarian borderline tumour) except for functional cysts on pelvic ultrasound
- Germline BRCA1/2 testing results not provided by an ISO 1589 accredited laboratory
- Refusal to provide written informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Actively Recruiting
Research Team
C
Camilla Nero
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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