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NCT Number: NCT06902935

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

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.

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Key information

Conditions

Breast Cancer Screening

Age range

30 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Taizhou Central Hospital (Affiliated Hospital of Taizhou University)

Taizhou, Zhejiang, 318000, China

Location contact

sunmengwei

CONTACT

[email protected]

008619804632150

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Tongue appearance collection (overall tongue color)

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

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

  2. Tongue appearance collection (overall tongue coating color)

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

    white, yellow, no tongue coating

  3. Tongue appearance collection (thickness of the tongue coating)

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

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

  4. Pulse condition collection (pulse strength)

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

    forceful, moderate, weak

  5. Pulse condition collection (pulse rhythm)

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

    Regular, rapid intermittent pulse, slow intermittent pulse.

  6. Pulse condition collection (pulse rate)

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

    Slow pulse, moderate pulse, normal pulse, rapid pulse, extremely rapid pulse.

  7. Collection of facial appearances (overall facial complexion)

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

    Normal facial complexion, white complexion, yellow complexion, red complexion, cyan complexion, black complexion

  8. Collection of facial appearances (overall luster)

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

    With luster, without luster

  9. Judgment of Constitution Score

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

sunmengwei

CONTACT

[email protected]

008619804632150

Sponsors and collaborators

Lead sponsor

Taizhou Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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