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

NCT07063667 | Not Yet Recruiting

• 1 other identifier: Ratification NO: 2025（188）
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• AUC (Area Under the ROC Curve)

  Baseline-AUC1 Perioperative/Periprocedural-AUC2

Study Arms (2)

training group

Other: bulid primary AI model

verdict group

Other: verdict model and develop its function

Interventions

bulid primary AI model 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.

training group

verdict model and develop its function OTHER

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

verdict group

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospectively collect the clinical data, breast MRI images, breast ultrasound images and reports, laboratory indicators (such as CA199, CA153, CA125, CEA/AEP), 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 who were pathologically confirmed with breast cancer 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+ between January 2019 and December 2024, additional immunohistochemical staining for CD8A, KPT5, GFRA1, and PFKP should be performed, and the immunohistochemical images and results should be collected.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Army medical Cnter

Chongqing, Chongqing Municipality, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xu Yan

CONTACT

8615923100038; xy931@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: July 14, 2025
• Study Start: August 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)