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Trial Title:
PREDICTION OF GERMLINE BRCA 1/2 GENES FROM HEALTHY OVARIES
NCT ID:
NCT05769517
Condition:
BRCA Mutation
Ovarian Cancer
Ultrasound Therapy; Complications
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Germinal BRCA
Description:
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.
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.
Criteria for eligibility:
Study pop:
We will conduct a retrospective multicenter observational study aimed at collecting US
images of healthy ovaries with known BRCA status.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Gender based:
Yes
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Rome
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Camilla Nero, PhD
Phone:
0630158667
Email:
camilla.nero@policlinicogemelli.it
Start date:
March 20, 2023
Completion date:
May 2, 2026
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05769517
