Clinical trial NCT06136026: Integrated Chinese and Western Medicine Specialized Disease Cohort for Colorectal Cancer
Official title: Integrative Chinese and Western Medicine for Colorectal Cancer: A Nationwide Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Cancer
Colorectal Adenoma
Lead sponsor: Jiangsu Famous Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Jiangsu Province Hospital of Traditional Chinese Medicine
name: Peking University Cancer Hospital & Institute
name: Fujian Cancer Hospital
name: Hubei Cancer Hospital
name: Shandong Cancer Hospital and Institute
name: Shanxi Province Cancer Hospital
name: Sichuan Cancer Hospital and Research Institute
name: Yunnan Cancer Hospital
name: Zhejiang Cancer Hospital
name: Xiangya Hospital of Central South University
name: Chongqing University Cancer Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: First Affiliated Hospital of Guangxi Medical University
name: First Affiliated Hospital of Harbin Medical University
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Tianjin Medical University Cancer Institute and Hospital
name: Gansu Cancer Hospital
First posted: 2023-11-18
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival of patients with CRC
timeFrame: 5 years
measure: The detection rate of Colorectal Adenomatous Polyp.
timeFrame: 5 years
Secondary outcomes:
measure: Quality of life of CRC patients
timeFrame: 5 years
measure: Recurrence rate of CRC patients
timeFrame: 5 years
measure: Metastasis rate of CRC patients
timeFrame: 5 years
measure: Disease-free survival (DFS) of CRC patients
timeFrame: 5 years
measure: Progression-free survival (PFS) of CRC patients
timeFrame: 5 years
measure: The canceration rate of Colorectal Adenomatous Polyp.
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Affiliated Hospital of Nanjing University of Chinese Medicine
name: Hai bo Cheng, Professor
role: STUDY_CHAIR
References: