Integrated Chinese and Western Medicine Specialized Disease Cohort for Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06136026
• Other study ID #: ZLXTCXZX-2023001
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 31, 2033

Study information

• Verified date: November 2023
• Source: Jiangsu Famous Medical Technology Co., Ltd.
• Contact: Hai bo Cheng, Professor
• Phone: 025-85811001
• Email: hbcheng[@]njucm.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50000
• Est. completion date: December 31, 2033
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (19)

Lead Sponsor

Collaborator

Jiangsu Famous Medical Technology Co., Ltd.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Chongqing University Cancer Hospital, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Harbin Medical University, Fujian Cancer Hospital, Gansu Cancer Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Hubei Cancer Hospital, Jiangsu Province Hospital of Traditional Chinese Medicine, Peking University Cancer Hospital & Institute, Shandong Cancer Hospital and Institute, Shanxi Province Cancer Hospital, Sichuan Cancer Hospital and Research Institute, The First Affiliated Hospital of Anhui Medical University, Tianjin Medical University Cancer Institute and Hospital, Xiangya Hospital of Central South University, Yunnan Cancer Hospital, Zhejiang Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival of patients with CRC	Patients were recorded from the time they entered the study until their final death.	5 years
Primary	The detection rate of Colorectal Adenomatous Polyp.	In the follow-up plan, record the proportion of patients diagnosed with colorectal adenoma after colonoscopy examination.	5 years
Secondary	Quality of life of CRC patients	The quality of life will be evaluated using the KPS score. The higher the KPS score, the better the patient's health condition.	5 years
Secondary	Recurrence rate of CRC patients	Record the number of patients with recurrence at each time point.	5 years
Secondary	Metastasis rate of CRC patients	Record the number of patients with metastasis at each time point.	5 years
Secondary	Disease-free survival (DFS) of CRC patients	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.	5 years
Secondary	Progression-free survival (PFS) of CRC patients	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.	5 years
Secondary	The canceration rate of Colorectal Adenomatous Polyp.	In the follow-up plan, record the proportion of patients diagnosed with colorectal cancer after colonoscopy examination.	5 years