Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT07063667
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-14
First Post:
2025-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Artificial Intelligence Model-Assisted Accurate Diagnosis of Early-Stage Breast Cancer
Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Organization:
Study Overview
Official Title:
Artificial Intelligence Model-Assisted Accurate Diagnosis of Early-Stage Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: