Prediction of Germline BRCA 1/2 Genes From Healthy Ovaries

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Radiogenomics model for predicting germline breast cancer. — 96 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 sites (1)

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