Recruiting

NCT Number: NCT05769517

Prediction of Germline BRCA 1/2 Genes From Healthy Ovaries

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.

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Key information

Conditions

BRCA Mutation Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Ultrasound Therapy; Complications Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Location status: Recruiting

Location contact

Camilla Nero, PhD

CONTACT

[email protected]

0630158667

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Germinal BRCA

Diagnostic Test

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.

Primary outcomes

Radiogenomics model for predicting germline breast cancer.

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla Nero

CONTACT

[email protected]

+390630156779

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Prediction of Germline BRCA 1/2 Genes Pathogenetic Variants From Healthy Ovaries Ultrasound Images: Radiogenomics as an Innovative Tool to Prevent BRCA-related Cancers

Acronym: PROBE-II

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2031
First posted: Mar 15, 2023
Registry last updated: Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting