Prediction of Germline BRCA 1/2 Genes From Healthy Ovaries
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
We will conduct a retrospective multicenter observational study aimed at collecting US images of healthy ovaries with known BRCA status.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Germinal BRCA
Diagnostic testWe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Radiogenomics model for predicting germline breast cancer.
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.
Time frame
96 monthsSponsors and contacts
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Source ClinicalTrials.gov