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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age30-75
SponsorTaizhou Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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).

  • 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.

Treatment groups

1,500 Participants
are divided into 2 treatment groups
Group A: Case group1 intervention
Group B: Control group1 intervention

Trial outcomes

Primary outcomes

1

Tongue appearance collection (overall tongue color)

pale white, pale purple, light red, dark red, dark purple

Time frame
through study completion, an average of 1 year
2

Tongue appearance collection (overall tongue coating color)

white, yellow, no tongue coating

Time frame
through study completion, an average of 1 year
3

Tongue appearance collection (thickness of the tongue coating)

Thin tongue coating, thick tongue coating, scanty tongue coating or no tongue coating

Time frame
through study completion, an average of 1 year
4

Pulse condition collection (pulse strength)

forceful, moderate, weak

Time frame
through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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