跳至主要内容
临床试验/NCT06136026
NCT06136026尚未招募不适用

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

Jiangsu Famous Medical Technology Co., Ltd.0 个研究点目标入组 50,000 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50,000
主要终点
The detection rate of Colorectal Adenomatous Polyp.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

The detection rate of Colorectal Adenomatous Polyp.

时间窗: 5 years

In the follow-up plan, record the proportion of patients diagnosed with colorectal adenoma after colonoscopy examination.

Overall survival of patients with CRC

时间窗: 5 years

Patients were recorded from the time they entered the study until their final death.

次要结局

  • Progression-free survival (PFS) of CRC patients(5 years)
  • Metastasis rate of CRC patients(5 years)
  • Disease-free survival (DFS) of CRC patients(5 years)
  • The canceration rate of Colorectal Adenomatous Polyp.(5 years)
  • Quality of life of CRC patients(5 years)
  • Recurrence rate of CRC patients(5 years)

研究者

申办方类型
Industry
责任方
Sponsor

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