About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged between 30 and 75.
Patients who have a mass detected by US examination, need to undergo surgery or needle biopsy, and obtain a definite pathological result.
Patients who have obtained complete identification results of tongue, pulse, face, and constitution through the traditional Chinese medicine four diagnostic instruments.
Disqualifiers
None
Trial population
Patients with breast masses who come to the clinic for medical treatment
Trial design
Case-control
Prospective
Treatments tested in this trial
Diagnosis of Breast Cancer by Traditional Chinese Medicine Four Examinations
Diagnostic testThe 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).
Ultrasound diagnosis of breast cancer
Diagnostic testProfessional 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.
Treatment groups
Trial outcomes
Primary outcomes
Tongue appearance collection (overall tongue color)
pale white, pale purple, light red, dark red, dark purple
Tongue appearance collection (overall tongue coating color)
white, yellow, no tongue coating
Tongue appearance collection (thickness of the tongue coating)
Thin tongue coating, thick tongue coating, scanty tongue coating or no tongue coating
Pulse condition collection (pulse strength)
forceful, moderate, weak
Sponsors and contacts
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