Prediction of Germline BRCA 1/2 Genes Pathogenetic Variants From Healthy Ovaries Ultrasound Images: Radiogenomics as an Innovative Tool to Prevent BRCA-related Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,465
- 试验地点
- 1
- 主要终点
- Radiogenomics model for predicting germline breast cancer.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Radiogenomics model for predicting germline breast cancer.
时间窗: 36 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.
Radiogenomics model for predicting germline breast cancer.
时间窗: 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.
次要结局
未报告次要终点