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NCT06902935

Establishment and Clinical Application of Breast Cancer Risk Prediction Model Based on Traditional Chinese Medicine Four Diagnostic Instruments and Ultrasound

Sponsor: Taizhou Hospital

View on ClinicalTrials.gov

Summary

Construct a breast cancer risk prediction model based on traditional Chinese medicine four diagnostic instruments and B-ultrasound images. Ensure that the key evaluation indicators of the model reach a high level through clinical verification, so as to contribute to accurate clinical diagnosis and treatment decision-making.

Key Details

Gender

FEMALE

Age Range

30 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

1500

Start Date

2025-04-26

Completion Date

2027-04-26

Last Updated

2025-03-30

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Diagnosis of Breast Cancer by Traditional Chinese Medicine Four Examinations

The Daosheng TCM Four-Diagnostic Instrument (DS01-A) comprehensively collects patients' TCM four-diagnostic information, covering tongue (e.g., overall color, coating color/thickness/greasiness, tooth marks, etc.), pulse (e.g., position, force, rhythm, etc.), face (e.g., overall color, luster, lip color/dryness, etc.) and constitution scores (quantifying 9 constitutions via the TCM Constitution Classification Table).

DIAGNOSTIC_TEST

Ultrasound diagnosis of breast cancer

Professional ultrasound physicians use B - ultrasound equipment of the same model to accurately collect detailed parameters of breast masses according to a standardized process. These parameters include shape (oval, round, irregular), orientation (parallel, non - parallel), margin (smooth, non - smooth, with non - smooth including blurred, angular, microlobulated, spiculated, etc.), echo pattern (anechoic, hyperechoic, complex cystic - solid echo, hypoechoic, isoechoic, heterogeneous echo), posterior echo characteristics (no change, enhancement, shadowing, mixed), calcification (microcalcification and coarse calcification within the mass, calcification outside the mass, intraductal), and vascular supply (no blood supply, internal blood supply, marginal blood supply), etc.

Locations (1)

Taizhou Central Hospital (Affiliated Hospital of Taizhou University)

Taizhou, Zhejiang, China