Integrated Chinese and Western Medicine Specialized Disease Cohort for Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Colorectal Adenoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Integrative Chinese and Western Medicine for Colorectal Cancer: A Nationwide Prospective Cohort Study
Overview
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.
Detailed description
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.
Primary outcome measures
- Overall survival of patients with CRC [Time frame: 5 years]
- The detection rate of Colorectal Adenomatous Polyp. [Time frame: 5 years]
Secondary outcome measures (6)
- Quality of life of CRC patients [Time frame: 5 years]
- Recurrence rate of CRC patients [Time frame: 5 years]
- Metastasis rate of CRC patients [Time frame: 5 years]
- Disease-free survival (DFS) of CRC patients [Time frame: 5 years]
- Progression-free survival (PFS) of CRC patients [Time frame: 5 years]
- The canceration rate of Colorectal Adenomatous Polyp. [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
Identifiers
NCT: NCT06136026 · ZLXTCXZX-2023001