BRCA Mutation, Ovarian Cancer, Ultrasound Therapy; Complications
Conditions
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: 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.
Interventions
DIAGNOSTIC_TESTGerminal 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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
CONTACTCamilla Nero
PRINCIPAL_INVESTIGATORCamilla Nero
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Outcome results
None listed