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

NCT06902935 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2025-03-30

No results posted yet for this study

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

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), 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.

Sponsors & Collaborators

  • Taizhou Hospital

    lead OTHER

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-26
Primary Completion
2027-04-26
Completion
2027-04-26

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06902935 on ClinicalTrials.gov