Colorectal Cancer and Advanced Precancerous Neoplasm Screening Using Stool DNA-based SDC2 and SFRP2 Methylation Test in China, a Multi-Center Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Neoplasm
- Sponsor
- Changhai Hospital
- Enrollment
- 4800
- Primary Endpoint
- Sensitivity, specificity, positive predictive value and negative predictive value of bi-target stool DNA testing (the methylation status of SDC2 and SFRP2) with comparison to colonoscopy, both with respect to cancer and advanced precancerous neoplasm.
- Last Updated
- 5 years ago
Overview
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 colorectal cancer and advanced precancerous neoplasm(including advanced adenoma and advanced serrated lesions) screening, using colonoscopy as the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination.
The secondary objective is to compare the performance of the bi-target stool DNA testing to a commercially available fecal immunochemical test (FIT) assay, both with respect to cancer and advanced precancerous neoplasm. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
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 Medical University), which is conducted at about 30 digestive endoscopy centers nationwide in China, with the expectation of including approximately 4,800 patients. Subjects willing to conduct colonoscopy examination will be asked to collect stool sample prior to bowl preparation for stool DNA test and commercially available FIT assay. The basic characteristics of subjects, bowel preparation method and quality, and related information of colonoscopy are recorded in detail. Colonoscopy and histopathologic examination are used as reference.
Investigators
Zhaoshen Li
MD, Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator, Clinical Professor
Changhai Hospital
Eligibility Criteria
Inclusion Criteria
- •Age between 40 to 85 years old, the gender is not limited
- •Willing to provide written consent
- •Able to provide stool sample
Exclusion Criteria
- •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
- •Subject taking anticoagulants such as aspirin and warfarin, or who have coagulopathy
- •Subject clinically highly suspected with gastrointestinal cancer
Outcomes
Primary Outcomes
Sensitivity, specificity, positive predictive value and negative predictive value of bi-target stool DNA testing (the methylation status of SDC2 and SFRP2) with comparison to colonoscopy, both with respect to cancer and advanced precancerous neoplasm.
Time Frame: Through study completion, an average of 1 year
A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination. Advanced precancerous neoplasm includes both advanced adenoma and advanced serrated lesions. The DNA test includes the methylation status of SDC2 and SFRP2. The tests were processed independently of colonoscopy procedure.
Secondary Outcomes
- To compare the performance of the bi-target stool DNA testing to a commercially available FIT assay, both with respect to cancer and advanced precancerous neoplasm.(Through study completion, an average of 1 year)