NCT05769517Recruiting
Prediction of Germline BRCA 1/2 Genes From Healthy Ovaries
Prediction of Germline BRCA 1/2 Genes Pathogenetic Variants From Healthy Ovaries Ultrasound Images: Radiogenomics as an Innovative Tool to Prevent BRCA-related Cancers
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 6465 (estimated)
- First submitted
- 3 Mar 2023
- Start date
- 20 Mar 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Ovarian cancer, Childhood cancers
- NCT number
- NCT05769517
What you commit to
- Study type: Observational
- Planned participants: 6465
- From 20 Mar 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- gBRCA1/2 testing results nor provided by an ISO 1589 accredited laboratory
Other
- 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
- Refusal to provide written informed consent
Who the study is looking for
- 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.
Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.