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

Taizhou Hospital

Status: Not yet enrolling

Conditions: Breast Cancer Screening

Treatments: Diagnostic Test: Ultrasound diagnosis of breast cancer; Diagnostic Test: Diagnosis of Breast Cancer by Traditional Chinese Medicine Four Examinations

Study type: Observational

Funder types: Other

Identifiers

NCT06902935

2025L-02-012

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,500 participants in 2 patient groups

Case group

Description:

The patients included in the group are those whose pathological results of breast masses are malignant.

Treatment:

Diagnostic Test: Diagnosis of Breast Cancer by Traditional Chinese Medicine Four Examinations

Control group

Description:

The patients included in this group are those whose pathological results of breast masses are benign.

Treatment:

Diagnostic Test: Ultrasound diagnosis of breast cancer