Status:
COMPLETED
Establishment of Molecular Classification Models for Early Diagnosis of Digestive System Cancers
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
Xuhui Central Hospital, Shanghai
Changhai Hospital
Conditions:
Esophageal Cancer
Gastric (Stomach) Cancer
Eligibility:
All Genders
18-80 years
Brief Summary
This is a single blind, case control, multicenter study jointly developed by Zhongshan Hospital of Fudan University, Shanghai Public Health Clinical Center, Shanghai Xuhui Central Hospital, Qingpu Bra...
Detailed Description
Design of the project: 1) Participants who sign informed consent forms will complete the disease history information collection;2) Collect samples of cancer tissue and corresponding paracancer samples...
Eligibility Criteria
Inclusion
- Colorectal cancer, Esophageal cancer and Gastric (stomach) cancer Group
- Aged 18 to 80, no gender limitation, no pregnant or breastfeeding for women;
- Those who can accept gastroscopy and/or total colonoscopy;
- Newly-diagnosed patients who had not received surgery, radiotherapy, chemotherapy, targeted therapy or other anti-tumor intervention;
- Stop anticoagulant drugs such as warfarin, aspirin, and bolivir for 1 week, and stop low molecular weight heparin that day;
- No previous history of other tumor diseases, and no abnormalities in the liver and kidney;
- No major trauma requiring blood transfusion treatment within one week.
Exclusion
- Previous esophageal cancer, stomach cancer, bowel cancer and gastrointestinal adenoma;
- Have a history of other cancers;
- Systemic inflammatory response syndrome;
- Previously experienced esophageal, gastric or colorectal adenoma removal or tumor resection;
- Patients with Lynch syndrome in the family;
- A history of severe cardiovascular disease (e.g., previous myocardial infarction, coronary artery bypass grafting, coronary stenting, congestive heart failure, myocardial infarction within 6 months, or uncontrolled severe hypertension, etc.) who were deemed unsuitable for inclusion by the investigator;
- Have participated in an "interventional" clinical trial within the past 30 days and have taken the experimental drug;
- Unsuitable for this trial determined by the researchers;
- Failure to collect blood on time according to plan;
- The blood sample does not meet the requirements.
- Hepatocellular Carcinoma Group
- Inclusion Criteria:
- Applicable to all enrolled volunteers (1) Aged 18 to 80, no gender limitation, no pregnant or breastfeeding for women; (2) No previous history of malignancy in other sites; (3) To avoid the risk of bleeding caused by taking anticoagulants during sampling, the following provisions shall be made according to different types of samples: stop anticoagulant drugs such as warfarin, aspirin, and bolivir for 1 week, and stop low molecular weight heparin that day; the doctor in charge decides whether to stop anticoagulant drugs before blood draw, according to the specific situation of the volunteers, ; (4) No major trauma requiring blood transfusion treatment within one week;
- Only for patients with hepatocellular carcinoma (HCC). (1) Diagnosed with stage I-IV hepatocellular carcinoma; (2) Newly-diagnosed patients with liver cancer, who had not received surgery, radiotherapy, chemotherapy, targeted therapy or other anti-tumor intervention;
- Only for high-risk groups (1) Diagnosis of child-Pugh grade A or B, chronic hepatitis B or cirrhosis; (2) No history of liver cancer or malignancy in other sites;
- For healthy people only (1) Normal liver function test results on the day of blood collection; (2) No history of hepatitis B, hepatitis C and cirrhosis; (3) No history of liver cancer or malignancy in other sites.
Key Trial Info
Start Date :
November 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
2430 Patients enrolled
Trial Details
Trial ID
NCT05431621
Start Date
November 15 2020
End Date
July 31 2023
Last Update
January 29 2025
Active Locations (4)
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1
Xuhui Central Hospital, Shanghai
Shanghai, Shanghai Municipality, China, 200030
2
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200030
3
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China, 201500
4
Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 201700