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

Not yet recruitingOBSERVATIONAL
Enrollment

1,500

Participants

Timeline

Start Date

April 26, 2025

Primary Completion Date

April 26, 2027

Study Completion Date

April 26, 2027

Conditions
Breast Cancer Screening
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.

Trial Locations (1)

318000

Taizhou Central Hospital (Affiliated Hospital of Taizhou University), Taizhou

All Listed Sponsors
lead

Taizhou Hospital

OTHER