Integrated Chinese and Western Medicine Specialized Disease Cohort for Colorectal Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJiangsu Famous Medical Technology Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient is over 18 years old;
The patient meets the diagnostic criteria for colorectal cancer;
The patient has not received anti-tumor treatment such as surgery, chemotherapy, radiotherapy, targeted therapy, or immunity in the past;
The patient voluntarily participated in this study and signed an informed consent form.
Disqualifiers
Combined with other malignant tumors;
The patient has severe cognitive impairment, dementia, and various mental disorders.
The patient had a history of malignancy;
The patient has severe cognitive impairment, dementia, and various mental disorders.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50,000 Participants
are grouped into 3 trial groupsGroup A: Rectal cancer cohort
Group B: Colon cancer cohort
Group C: Colorectal adenoma cohort
Trial outcomes
Primary outcomes
1
Overall survival of patients with CRC
Patients were recorded from the time they entered the study until their final death.
Time frame
5 years2
The detection rate of Colorectal Adenomatous Polyp.
In the follow-up plan, record the proportion of patients diagnosed with colorectal adenoma after colonoscopy examination.
Time frame
5 yearsSecondary outcomes
1
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.
Time frame
5 years2
Recurrence rate of CRC patients
Record the number of patients with recurrence at each time point.
Time frame
5 years3
Metastasis rate of CRC patients
Record the number of patients with metastasis at each time point.
Time frame
5 years4
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.
Time frame
5 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jiangsu Famous Medical Technology Co., Ltd.
Lead sponsor
Jiangsu Province Hospital of Traditional Chinese Medicine
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
Fujian Cancer Hospital
Collaborator
Hubei Cancer Hospital
Collaborator
Shandong Cancer Hospital and Institute
Collaborator
Shanxi Province Cancer Hospital
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Yunnan Cancer Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Chongqing University Cancer Hospital
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Gansu Cancer Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: