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Набор скоро начнётся NCT06136026

Integrated Chinese and Western Medicine Specialized Disease Cohort for Colorectal Cancer

— Наблюдательное Colorectal Cancer Colorectal Adenoma

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Colorectal Cancer, Colorectal Adenoma. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Integrative Chinese and Western Medicine for Colorectal Cancer: A Nationwide Prospective Cohort Study

Обзор

This is a nationwide cohort study on integrated traditional Chinese and Western medicine for colorectal cancer. The aim is to elucidate the distribution patterns of TCM syndromes in colorectal cancer and colorectal adenoma, reveal the relationship between TCM syndromes and diagnosis, prognosis, and prognosis. Based on biological samples, a phenotypic omics study of TCM syndromes in colorectal cancer and colorectal adenoma is conducted.

Подробное описание

Colorectal cancer (CRC) is a common malignant tumor. The global cancer data in 2020 shows that the incidence rate of CRC ranks the third in the world, and the mortality rate ranks the second in the world. China is a large country of CRC. In 2016, China's incidence rate of CRC ranked second in malignant tumors, and its mortality ranked fourth. Both incidence rate and mortality are on the rise. At present, studies have shown that TCM plays an important role in the prevention and treatment of precancerous lesions, recurrence, and metastasis of CRC throughout the entire process. However, the clinical efficacy and mechanism of TCM intervention in the onset, progression, and metastasis of CRC still need further research evidence to support. This project aims to address the above issues, based on the advantages of TCM in tumor prevention and treatment, and actively construct the first large-scale integrated traditional Chinese and Western medicine CRC specialized disease queue in China. The study focuses on the key links of the "precancerous lesions, recurrence, and metastasis" progress of CRC and conducts a combination of disease and syndrome queue research. The project is based on the team's preliminary research results and collaborates with multiple regional diagnosis and treatment centers in China to form high-quality evidence-based medical evidence and unify TCM syndrome differentiation standards for CRC. At the same time, based on the study of specialized disease cohorts, the project breaks through the phenotype omics of TCM, further revealing the biological connotation of TCM syndromes in colorectal cancer, achieving the integration of Chinese and Western medicine, breaking through the bottleneck of basic research on CRC in TCM, assisting the research process of traditional Chinese medicine in preventing and treating CRC, and promoting the modernization of TCM.

Первичные конечные точки

  • Overall survival of patients with CRC [Срок оценки: 5 years]
  • The detection rate of Colorectal Adenomatous Polyp. [Срок оценки: 5 years]
Вторичные конечные точки (6)
  • Quality of life of CRC patients [Срок оценки: 5 years]
  • Recurrence rate of CRC patients [Срок оценки: 5 years]
  • Metastasis rate of CRC patients [Срок оценки: 5 years]
  • Disease-free survival (DFS) of CRC patients [Срок оценки: 5 years]
  • Progression-free survival (PFS) of CRC patients [Срок оценки: 5 years]
  • The canceration rate of Colorectal Adenomatous Polyp. [Срок оценки: 5 years]

Критерии участия

Критерии включения

CRC patients:

  • The patient is over 18 years old;
  • The patient meets the diagnostic criteria for colorectal cancer;
  • The patient has not received anti-tumor treatment such as surgery, chemotherapy, radiotherapy, targeted therapy, or immunity in the past;
  • The patient voluntarily participated in this study and signed an informed consent form.

Colorectal adenoma patients

  • The patient is over 18 years old;
  • The patient meets the diagnostic criteria for colorectal adenoma;
  • The patient voluntarily participated in this study and signed an informed consent form.

Критерии исключения

CRC patients:

  • Combined with other malignant tumors;
  • The patient has severe cognitive impairment, dementia, and various mental disorders.

Colorectal adenoma patients:

  • The patient had a history of malignancy;
  • The patient has severe cognitive impairment, dementia, and various mental disorders.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Hui YF, Song SC, Zhu WJ, Bu S, Sun J, Ling TS, Cheng HB. Multicenter prospective cohort study on colorectal adenoma recurrence and malignant transformation risk based on integrative medicine: a study protocol. Front Oncol. 2025 Oct 27;15:1657390. doi: 10.3389/fonc.2025.1657390. eCollection 2025. PMID 41220937

Идентификаторы

NCT: NCT06136026 · ZLXTCXZX-2023001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗