Artificial Intelligence Model-Assisted Accurate Diagnosis of Early-Stage Breast Cancer

NCT ID: NCT07063667

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-10-31

Brief Summary

Retrospectively collect the clinical data, breast MRI images, breast ultrasound images and reports, laboratory indicators (such as CA199, CA153, CA125, CEA/AFP), pathological diagnosis results, HE staining images, and existing immunohistochemical results (including CD8A, KPT5, GFRA1, PFKP, ER/PR percentage, Her-2 expression, Ki-67 index, etc.) of patients pathologically confirmed with or excluded from breast cancer in our center between January 2019 and December 2024. For biopsy specimens from patients diagnosed with breast cancer and immunohistochemically confirmed as HR+/Her-2+ during the same period, additional immunohistochemical staining for CD8A, KPT5, GFRA1, and PFKP should be performed, with images and results collected.

The collected basic clinical information, imaging data, pathological findings, and laboratory metrics of patients will serve as candidate inputs. Units of measurement will be standardized, and missing data will be imputed using the multiple imputation by chained equations algorithm. Data harmonization will employ the Box-Cox algorithm, while min-max scaling will be used for standardization. The adaptive synthetic sampling method with a balance ratio of 0.5 will address data imbalance. For the collected patient data, deep learning will be applied to screen features from the images, combined with clinical significance to identify malignant risk factors. A neural network classifier will be trained on the training set data, with independent variables including breast MRI/ultrasound images, CA199, CA153, CA125, AFP/CEA, etc., and dependent variables including breast cancer status and subtype. Pathological biopsy results will be set as the validation standard.

Model tuning will be conducted on the validation set to construct a breast cancer prediction model. It should be noted that as a single-center study, the results have limited generalizability. The further optimization and evaluation plan for the model involves using breast disease screening data from external centers for validation and refinement, evaluating the model's practical impact on clinical decision-making, and continuously tracking and optimizing its performance.

Conditions

Breast Cancer, Metastatic; Artifical Intelligence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

training group

bulid primary AI model

Intervention Type: OTHER

For the collected patient data, deep learning is used to perform feature screening on the selected or collected images, and malignant risk factors are determined by combining clinical significance. A neural network classifier is trained on the training set data. Variable selection: independent variables (breast MRI images, breast ultrasound images, indicators such as CA199, CA153, CA125, AFP/CEA, etc.), dependent variables (whether suffering from breast cancer and breast cancer subtypes), and the verification accuracy standard is set as the pathological biopsy result.

verdict group

verdict model and develop its function

Intervention Type: OTHER

The accuracy of a breast cancer prediction model is typically evaluated using multiple metrics that assess its performance in different aspects

Interventions

bulid primary AI model

For the collected patient data, deep learning is used to perform feature screening on the selected or collected images, and malignant risk factors are determined by combining clinical significance. A neural network classifier is trained on the training set data. Variable selection: independent variables (breast MRI images, breast ultrasound images, indicators such as CA199, CA153, CA125, AFP/CEA, etc.), dependent variables (whether suffering from breast cancer and breast cancer subtypes), and the verification accuracy standard is set as the pathological biopsy result.

Intervention Type: OTHER

verdict model and develop its function

The accuracy of a breast cancer prediction model is typically evaluated using multiple metrics that assess its performance in different aspects

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients pathologically diagnosed with breast cancer or excluded from breast cancer
• Available pathological results of breast masses
• Involving diagnostic population onl

Exclusion Criteria

• Suffering from mental disorders
• Presence of non-breast diseases during examination
• Presence of breast implants
• Undergoing non-breast surgery or having received radiotherapy/chemotherapy
• Lactating or pregnant women
• Missing data

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Army medical Cnter

Chongqing, Chongqing Municipality, China

Countries

China

Central Contacts

Xu Yan

Role: CONTACT

xy931@163.com

8615923100038

Facility Contacts

Yan Xu

Role: primary

xy931@163.com

8615923100038

Other Identifiers

Ratification NO: 2025（188）

Identifier Type: -

Identifier Source: org_study_id