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

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 Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Screening
• Intervention / Treatment: Diagnostic test: Diagnosis of Breast Cancer by Traditional Chinese Medicine Four Examinations; Diagnostic test: Ultrasound diagnosis of breast cancer

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: sunmengwei; Phone Number: 008619804632150; Email: 935275820@qq.com

Study Locations

• China
  • Zhejiang
    • Taizhou, Zhejiang, China, 318000
      • Taizhou Central Hospital (Affiliated Hospital of Taizhou University)
      • Contact: sunmengwei; Phone Number: 008619804632150; Email: 935275820@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with breast masses who come to the clinic for medical treatment

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case group; The patients included in the group are those whose pathological results of breast masses are malignant.	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).
Control group; The patients included in this group are those whose pathological results of breast masses are benign.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tongue appearance collection (overall tongue color)	pale white, pale purple, light red, dark red, dark purple	through study completion, an average of 1 year
Tongue appearance collection (overall tongue coating color)	white, yellow, no tongue coating	through study completion, an average of 1 year
Tongue appearance collection (thickness of the tongue coating)	Thin tongue coating, thick tongue coating, scanty tongue coating or no tongue coating	through study completion, an average of 1 year
Pulse condition collection (pulse strength)	forceful, moderate, weak	through study completion, an average of 1 year
Pulse condition collection (pulse rhythm)	Regular, rapid intermittent pulse, slow intermittent pulse.	through study completion, an average of 1 year
Pulse condition collection (pulse rate)	Slow pulse, moderate pulse, normal pulse, rapid pulse, extremely rapid pulse.	through study completion, an average of 1 year
Collection of facial appearances (overall facial complexion)	Normal facial complexion, white complexion, yellow complexion, red complexion, cyan complexion, black complexion	through study completion, an average of 1 year
Collection of facial appearances (overall luster)	With luster, without luster	through study completion, an average of 1 year
Judgment of Constitution Score	Balanced constitution, Qi-deficiency constitution, Yang-deficiency constitution, Yin-deficiency constitution, Phlegm-dampness constitution, Damp-heat constitution, Blood-stasis constitution, Qi-stagnation constitution, Special constitution.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Taizhou Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 26, 2025
• Primary Completion (Estimated): April 26, 2027
• Study Completion (Estimated): April 26, 2027

Study Registration Dates

• First Submitted: February 16, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2025L-02-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No