Predicting BRCA gene status from healthy ovarian ultrasound images
Official title: Prediction of Germline BRCA 1/2 Genes Pathogenetic Variants From Healthy Ovaries Ultrasound Images: Radiogenomics as an Innovative Tool to Prevent BRCA-related Cancers
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05769517 · Data updated 2026-11-12
This study is testing if ultrasound images of healthy ovaries can help predict whether women carry the BRCA gene that increases their risk for breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Women only |
| Enrollment | 6465 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Status | Recruiting |
| Started | March 20, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | March 8, 2031 |
| Registry record updated | April 24, 2026 |
| Trial ID | NCT05769517 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women with healthy ovaries who have undergone transvaginal pelvic ultrasound and have available gBRCA1/2 test results.
✕Probably not a fit
Patients with a personal diagnosis of ovarian cancer or those with abnormal ovarian findings will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to enhance the prediction of germline BRCA1/2 gene status in women with healthy ovaries using ultrasound images. It consists of two phases: a retrospective phase that focuses on refining image processing and expanding the dataset with new images, and a prospective phase that validates the predictive model through an observational multicenter study. The study employs advanced techniques such as deep neural networks and radiomics analysis to improve accuracy in predicting breast cancer susceptibility.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for identifying women at risk for breast cancer based on ovarian imaging.
How similar studies have gone: While similar predictive models have been explored, this specific approach using ultrasound images and radiogenomics is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy Recruiting
Study contacts
- Principal investigator: Camilla Nero — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Camilla Nero
- Email: camilla.nero@policlinicogemelli.it
- Phone: +390630156779
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.