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

N/ANot Yet RecruitingNCT06902935

Taizhou Hospital1,500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Breast Cancer Screening

Interventions

Diagnosis of Breast Cancer by Traditional Chinese Medicine Four ExaminationsDIAGNOSTIC_TEST

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).

Ultrasound diagnosis of breast cancerDIAGNOSTIC_TEST

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.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female patients aged between 30 and 75. 2. Patients who have a mass detected by US examination, need to undergo surgery or needle biopsy, and obtain a definite pathological result. 3. Patients who have obtained complete identification results of tongue, pulse, face, and constitution through the traditional Chinese medicine four diagnostic instruments. Exclusion Criteria: \- 1. Patients with severe heart, liver, or kidney insufficiency, or other serious systemic diseases. 2\. Patients with a history of other malignant tumors. 3. Cases with poor - quality B - ultrasound images. 4. Cases with an unclear pathological diagnosis. 5. Patients with obvious lesions on the face, in the oral cavity, or on the tongue that may affect the measurement results.

Locations (1)

Taizhou Central Hospital (Affiliated Hospital of Taizhou University)

Taizhou, Zhejiang, China