Integrated Chinese and Western Medicine Specialized Disease Cohort for Colorectal Cancer

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Colorectal Adenoma

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 Type: Observational
• Enrollment (Estimated): 50000

Contacts and Locations

• Study Contact: Name: Hai bo Cheng, Professor; Phone Number: 025-85811001; Email: hbcheng@njucm.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Diagnostic criteria for CRC: refer to the diagnostic criteria in the 2023 Chinese Guidelines for Integrated Diagnosis and Treatment of Malignant Tumors - Colon Cancer Part. Diagnostic criteria for colorectal adenoma: Refer to the Western diagnostic criteria for colorectal adenoma in the Pathological Diagnosis Consensus of Gastrointestinal adenoma and Benign epithelial polyps published by the Digestive Diseases Group of the Pathology Society of the Chinese Medical Association.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Rectal cancer cohort; 20,000 patients with rectal cancer will be included in this cohort and followed for five years.
Colon cancer cohort; 20,000 patients with colon cancer will be included in this cohort and followed for five years.
Colorectal adenoma cohort; 10,000 patients with colorectal adenomas will be enrolled in this cohort and followed for five years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival of patients with CRC	Patients were recorded from the time they entered the study until their final death.	5 years
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Recurrence rate of CRC patients	Record the number of patients with recurrence at each time point.	5 years
Metastasis rate of CRC patients	Record the number of patients with metastasis at each time point.	5 years
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
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
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

Collaborators and Investigators

• Sponsor: Jiangsu Famous Medical Technology Co., Ltd.
• Collaborators: Zhejiang Cancer Hospital; Shanxi Province Cancer Hospital; Jiangsu Province Hospital of Traditional Chinese Medicine; The First Affiliated Hospital of Anhui Medical University; Chongqing University Cancer Hospital; Guangdong Provincial Hospital of Traditional Chinese Medicine; Xiangya Hospital of Central South University; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Fujian Cancer Hospital; Hubei Cancer Hospital; Peking University Cancer Hospital & Institute; Tianjin Medical University Cancer Institute and Hospital; Shandong Cancer Hospital and Institute; First Affiliated Hospital of Harbin Medical University; Sichuan Cancer Hospital and Research Institute; Yunnan Cancer Hospital; First Affiliated Hospital of Guangxi Medical University; Gansu Cancer Hospital
• Investigators: Study Chair: Hai bo Cheng, Professor, Nanjing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2033

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: ZLXTCXZX-2023001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No