Trial Title:
Integrated Chinese and Western Medicine Specialized Disease Cohort for Colorectal Cancer
NCT ID:
NCT06136026
Condition:
Colorectal Cancer
Colorectal Adenoma
Conditions: Official terms:
Colorectal Neoplasms
Adenoma
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 1, 2023
Completion date:
December 31, 2033
Lead sponsor:
Agency:
Jiangsu Famous Medical Technology Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Jiangsu Province Hospital of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Hubei Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Shandong Cancer Hospital and Institute
Agency class:
Other
Collaborator:
Agency:
Shanxi Province Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Collaborator:
Agency:
Yunnan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Anhui Medical University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Guangxi Medical University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Harbin Medical University
Agency class:
Other
Collaborator:
Agency:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Collaborator:
Agency:
Gansu Cancer Hospital
Agency class:
Other
Source:
Jiangsu Famous Medical Technology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06136026
