Status:
UNKNOWN
Colorectal Cancer Screening Using Stool DNA-based SDC2 and SFRP2 Methylation Test in China
Lead Sponsor:
Changhai Hospital
Conditions:
Colorectal Neoplasm
Colorectal Cancer
Eligibility:
All Genders
40-85 years
Brief Summary
The primary objective is to determine sensitivity, specificity, positive predictive value and negative predictive value of a bi-target stool DNA testing (the methylation status of SDC2 and SFRP2) for ...
Detailed Description
This study is a multi-center diagnostic test led by the National Clinical Research Center for Digestive Disease (Shanghai) (Department of Gastroenterology, Changhai Hospital, Navy/Second Military Medi...
Eligibility Criteria
Inclusion
- Age between 40 to 85 years old, the gender is not limited
- Willing to provide written consent
- Able to provide stool sample
Exclusion
- Unwilling to provide stool samples
- Subject with contraindications for bowel preparation or colonoscopy
- Subject with known colorectal polyps but not removed
- Subject with inflammatory bowel disease
- History of colonoscopy within 1 year
- History of colorectal cancer
- History of hereditary colorectal cancer syndrome (including polyposis)
- Active lower gastrointestinal bleeding
- Pregnancy
- Subject taking anticoagulants such as aspirin and warfarin, or who have coagulopathy
- Subject clinically highly suspected with gastrointestinal cancer
- Other conditions deemed not suited for the study by investigators
- Elimination Criteria:
- Ask to withdraw from the study
- Unable to get a stool sample
- Invalid stool samples to test
- Poor or inadequate bowel preparation
- Failed to complete the colonoscopy
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
4800 Patients enrolled
Trial Details
Trial ID
NCT04515082
Start Date
August 1 2020
End Date
August 1 2021
Last Update
August 18 2020
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