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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | The patients included in the group are those whose pathological results of breast masses are malignant. |
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| Control group | The patients included in this group are those whose pathological results of breast masses are benign. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Tongue appearance collection (overall tongue color) | pale white, pale purple, light red, dark red, dark purple | through study completion, an average of 1 year |
| Tongue appearance collection (overall tongue coating color) | white, yellow, no tongue coating | through study completion, an average of 1 year |
| Tongue appearance collection (thickness of the tongue coating) | Thin tongue coating, thick tongue coating, scanty tongue coating or no tongue coating | through study completion, an average of 1 year |
| Pulse condition collection (pulse strength) | forceful, moderate, weak | through study completion, an average of 1 year |
| Pulse condition collection (pulse rhythm) | Regular, rapid intermittent pulse, slow intermittent pulse. | through study completion, an average of 1 year |
| Pulse condition collection (pulse rate) | Slow pulse, moderate pulse, normal pulse, rapid pulse, extremely rapid pulse. | through study completion, an average of 1 year |
| Collection of facial appearances (overall facial complexion) | Normal facial complexion, white complexion, yellow complexion, red complexion, cyan complexion, black complexion | through study completion, an average of 1 year |
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Inclusion Criteria:
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.
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Patients with breast masses who come to the clinic for medical treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| sunmengwei | Contact | 008619804632150 | 935275820@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taizhou Central Hospital (Affiliated Hospital of Taizhou University) | Taizhou | Zhejiang | 318000 | China |
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| 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. |
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| Collection of facial appearances (overall luster) | With luster, without luster | through study completion, an average of 1 year |
| Judgment of Constitution Score | 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. | through study completion, an average of 1 year |