Integrated Chinese and Western Medicine Specialized Disease Cohort for Colorectal Cancer

Not yet recruiting

• Conditions: Colorectal Cancer; Colorectal Adenoma

• Registration Number: NCT06136026
• Lead Sponsor: Jiangsu Famous Medical Technology Co., Ltd.

Brief Summary

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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Study Start: 2023-12-01
• Primary Completion: 2028-12-31
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50000

Inclusion Criteria

CRC patients:

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

Colorectal adenoma patients

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

Exclusion Criteria

CRC patients:

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

Colorectal adenoma patients:

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The detection rate of Colorectal Adenomatous Polyp.	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	5 years	Patients were recorded from the time they entered the study until their final death.

Secondary Outcome Measures

Name	Time	Method
Metastasis rate of CRC patients	5 years	Record the number of patients with metastasis at each time point.
Disease-free survival (DFS) of CRC patients	5 years	The evaluation criteria for DFS are as follows: after radical treatment, the patient has reached a disease-free state or complete remission, and after this, the time span until the first assessment of tumor recurrence or metastasis or death without recurrence or metastasis, the patient is in a tumor free state at this stage.
Progression-free survival (PFS) of CRC patients	5 years	The evaluation criteria for PFS are as follows: the time span from the start of tumor treatment upon patient enrollment to the first assessment of disease progression or death without progression, during which the tumor has basically not progressed.
The canceration rate of Colorectal Adenomatous Polyp.	5 years	In the follow-up plan, record the proportion of patients diagnosed with colorectal cancer after colonoscopy examination.
Quality of life of CRC patients	5 years	The quality of life will be evaluated using the KPS score. The higher the KPS score, the better the patient's health condition.
Recurrence rate of CRC patients	5 years	Record the number of patients with recurrence at each time point.