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Clinical Trials/NCT04270032
NCT04270032
Recruiting
Not Applicable

To Build and Evaluate a Precise Diagnosis, Therapy Assessment and Prognosis Prediction Model of Breast Cancer Based on Artificial Intelligence

The First Affiliated Hospital of the Fourth Military Medical University1 site in 1 country10,000 target enrollmentFebruary 1, 2020
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
The First Affiliated Hospital of the Fourth Military Medical University
Enrollment
10000
Locations
1
Primary Endpoint
sensitivity
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this study is using a deep learning method to analyze the automated breast ultrasound (ABUS) and hand-held ultrasound(HHUS) images, establish and evaluate a diagnosis, therapy assessment and prognosis prediction model of breast cancer. The model would provide important references for further early prevention, early diagnosis and personalized treatment.

Detailed Description

1. Establishing a database By collecting ABUS, HHUS and comprehensive breast images data, essential information, clinical treatment information, prognosis, and curative effect information, a complete breast image database is constructed. 2. Marking ABUS images Three doctors use a semi-automatic method to frame the lesions on the image. 3. Building the model Using the deep learning method to preprocess, analyze and train the marked images, and finally get a model diagnosis, efficacy evaluation and prognosis prediction model of breast cancer. 4. Evaluating the model 1)Self-validation: Analyze the sensitivity, AUC of the breast cancer diagnosis model and the false-positive number on each ABUS volume. 2) Compared the sensitivity, AUC and the false-positive number with a commercial diagnosis model. 3)To test the screening and diagnostic efficacy of computer-aided diagnosis systems through prospective or retrospective studies. 4)By analyzing the size and characteristics of the lesions after neoadjuvant chemotherapy, and predicting the OS and DFS time, the therapy assessment and prognosis prediction model were evaluated.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
September 1, 2024
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
The First Affiliated Hospital of the Fourth Military Medical University
Responsible Party
Principal Investigator
Principal Investigator

Song Hongping

Principal Investigator

The First Affiliated Hospital of the Fourth Military Medical University

Eligibility Criteria

Inclusion Criteria

  • Female patients over 18 years old who come to the two centers for physical examination or treatment;
  • Complete basic information and image data

Exclusion Criteria

  • There is no complete ABUS and HHUS images data;
  • The image quality is poor;
  • In multifocal breast cancer, the correlation between the tumor in the image and the postoperative pathological examination is uncertain.

Outcomes

Primary Outcomes

sensitivity

Time Frame: 4 years

Proportion of corrected-marked malignant lesions by the model

area under curve

Time Frame: 4 years

area under receiver operating characteristic (ROC) curve in percentage (%)

false-positive per volume

Time Frame: 4 years

the number of uncorrected-marked malignant lesions by the model

overall survival(OS) time

Time Frame: up to 10 years

It measures the time from the date of cancer diagnosis to any cause of death.

Disease-free survival (DFS) time

Time Frame: up to 5 years

The time that the patient is free of the signs and symptoms of a disease after treatment.

Study Sites (1)

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