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Prediction of Germline BRCA 1/2 Genes From Healthy Ovaries

NCT05769517 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 6465

Last updated 2026-04-24

No results posted yet for this study

Summary

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

Interventions

DIAGNOSTIC_TEST

Germinal BRCA

We will conduct a multicenter prospective observational study aimed at automatically implementing the predictive model and collecting US images of healthy ovaries from patients tested for germline BRCA pathogenetic variants according to current indications.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Camilla Nero · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2026-12-31
Completion
2031-03-08

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05769517 on ClinicalTrials.gov