Establishment and Clinical Application of Breast Cancer Risk Prediction Model Based on Traditional Chinese Medicine Four Diagnostic Instruments and Ultrasound
NCT ID: NCT06902935
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1500 participants
OBSERVATIONAL
2025-04-26
2027-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case group
The patients included in the group are those whose pathological results of breast masses are malignant.
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.
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.
Interventions
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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).
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
30 Years
75 Years
FEMALE
No
Sponsors
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Taizhou Hospital
OTHER
Responsible Party
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Sun Mengwei
Establishment and Clinical Application of Breast Cancer Risk Prediction Model Based on Traditional Chinese Medicine Four Diagnostic Instruments and Ultrasound
Locations
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Taizhou Central Hospital (Affiliated Hospital of Taizhou University)
Taizhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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sunmengwei
Role: primary
Other Identifiers
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2025L-02-012
Identifier Type: -
Identifier Source: org_study_id