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临床试验/NCT07063667
NCT07063667尚未招募不适用

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

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
900
试验地点
1
主要终点
AUC (Area Under the ROC Curve)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
19 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

AUC (Area Under the ROC Curve)

时间窗: Baseline-AUC1 Perioperative/Periprocedural-AUC2

次要结局

未报告次要终点

研究者

发起方
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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