Меню
Набор скоро начнётся NCT06902935

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

— Наблюдательное Breast Cancer Screening

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Diagnosis of Breast Cancer by Traditional Chinese Medicine Four Examinations, Ultrasound diagnosis of breast cancer.
Кому может быть актуально
Состояния в реестре: Breast Cancer Screening. Базовые параметры: 30 лет — 75 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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.

Вмешательства

  • Диагностический тест Diagnosis of Breast Cancer by Traditional Chinese Medicine Four Examinations
    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).
  • Диагностический тест Ultrasound diagnosis of breast cancer
    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), post

Первичные конечные точки

  • Tongue appearance collection (overall tongue color) [Срок оценки: through study completion, an average of 1 year]
  • Tongue appearance collection (overall tongue coating color) [Срок оценки: through study completion, an average of 1 year]
  • Tongue appearance collection (thickness of the tongue coating) [Срок оценки: through study completion, an average of 1 year]
  • Pulse condition collection (pulse strength) [Срок оценки: through study completion, an average of 1 year]
  • Pulse condition collection (pulse rhythm) [Срок оценки: through study completion, an average of 1 year]
  • Pulse condition collection (pulse rate) [Срок оценки: through study completion, an average of 1 year]
  • Collection of facial appearances (overall facial complexion) [Срок оценки: through study completion, an average of 1 year]
  • Collection of facial appearances (overall luster) [Срок оценки: through study completion, an average of 1 year]
  • Judgment of Constitution Score [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

\- 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 1 центр
  • Taizhou Central Hospital (Affiliated Hospital of Taizhou University) — Taizhou

Идентификаторы

NCT: NCT06902935 · 2025L-02-012

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗