Menu
Not yet recruiting NCT06902935

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

— Observational Breast Cancer Screening

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diagnosis of Breast Cancer by Traditional Chinese Medicine Four Examinations, Ultrasound diagnosis of breast cancer.
Who it may be relevant to
Registry conditions: Breast Cancer Screening. Basic parameters: 30 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

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), post

Primary outcome measures

  • Tongue appearance collection (overall tongue color) [Time frame: through study completion, an average of 1 year]
  • Tongue appearance collection (overall tongue coating color) [Time frame: through study completion, an average of 1 year]
  • Tongue appearance collection (thickness of the tongue coating) [Time frame: through study completion, an average of 1 year]
  • Pulse condition collection (pulse strength) [Time frame: through study completion, an average of 1 year]
  • Pulse condition collection (pulse rhythm) [Time frame: through study completion, an average of 1 year]
  • Pulse condition collection (pulse rate) [Time frame: through study completion, an average of 1 year]
  • Collection of facial appearances (overall facial complexion) [Time frame: through study completion, an average of 1 year]
  • Collection of facial appearances (overall luster) [Time frame: through study completion, an average of 1 year]
  • Judgment of Constitution Score [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Taizhou Central Hospital (Affiliated Hospital of Taizhou University) — Taizhou

Identifiers

NCT: NCT06902935 · 2025L-02-012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗