Clinical trial NCT06902935: Establishment and Clinical Application of Breast Cancer Risk Prediction Model Based on Traditional Chinese Medicine Four Diagnostic Instruments and Ultrasound
Official title: Establishment and Clinical Application of Breast Cancer Risk Prediction Model Based on Traditional Chinese Medicine Four Diagnostic Instruments and Ultrasound
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer Screening
Lead sponsor: Taizhou Hospital
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast masses who come to the clinic for medical treatment

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Female patients aged between 30 and 75.
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:

- 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.

Primary outcomes:
measure: Tongue appearance collection (overall tongue color)
timeFrame: through study completion, an average of 1 year
measure: Tongue appearance collection (overall tongue coating color)
timeFrame: through study completion, an average of 1 year
measure: Tongue appearance collection (thickness of the tongue coating)
timeFrame: through study completion, an average of 1 year
measure: Pulse condition collection (pulse strength)
timeFrame: through study completion, an average of 1 year
measure: Pulse condition collection (pulse rhythm)
timeFrame: through study completion, an average of 1 year
measure: Pulse condition collection (pulse rate)
timeFrame: through study completion, an average of 1 year
measure: Collection of facial appearances (overall facial complexion)
timeFrame: through study completion, an average of 1 year
measure: Collection of facial appearances (overall luster)
timeFrame: through study completion, an average of 1 year
measure: Judgment of Constitution Score
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taizhou
country: China
facility: Taizhou Central Hospital (Affiliated Hospital of Taizhou University)
state: Zhejiang
Study officials:
References: