PREDICTION OF GERMLINE BRCA 1/2 GENES FROM HEALTHY OVARIES

Recruiting

• Conditions: Ultrasound Therapy; Complications; BRCA Mutation; Ovarian Cancer

• Registration Number: NCT05769517
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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:

Retrospective phase

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;

Prospective phase

AIM 3: To further cross-validate the predictive model on US images acquired prospectively in an observational multicenter study.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-15
• Study Start: 2023-03-20
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-22
• Primary Completion: 2024-04-01
• Study Completion: 2026-05-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiogenomics model for predicting germline breast cancer.	36 months	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.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy