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Recruiting NCT05769517

Prediction of Germline BRCA 1/2 Genes From Healthy Ovaries

Conditions: BRCA Mutation Ovarian Cancer Ultrasound Therapy; Complications

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
Germinal BRCA
DIAGNOSTIC_TEST
Locations 1
Italy (1)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Female only
Healthy volunteers
No
Start date
20.03.2023
Completion date
08.03.2031
Registry ID
NCT05769517
Source
clinicaltrials.gov
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