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

NCT06902935 | Not Yet Recruiting DMC

• 1 other identifier: 2025L-02-012
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Screening

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

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

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

Interventions

Diagnosis of Breast Cancer by Traditional Chinese Medicine Four Examinations DIAGNOSTIC_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).

Case group

Ultrasound diagnosis of breast cancer DIAGNOSTIC_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.

Control group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• \- 1. Patients with severe heart, liver, or kidney insufficiency, or other serious systemic diseases.
• \. 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.

Sponsors & Collaborators

• Taizhou Hospital: lead

Study Sites (1)

Taizhou Central Hospital (Affiliated Hospital of Taizhou University)

Taizhou, Zhejiang, 318000, China

Location

Central Study Contacts

sunmengwei

CONTACT

008619804632150; 935275820@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Establishment and Clinical Application of Breast Cancer Risk Prediction Model Based on Traditional Chinese Medicine Four Diagnostic Instruments and Ultrasound

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: March 30, 2025
• Study Start: April 26, 2025
• Primary Completion (Estimated): April 26, 2027
• Study Completion (Estimated): April 26, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-02

Locations

CN (1)