Colorectal Cancer Clinical Trial
Official title:
Colorectal Cancer and Advanced Precancerous Neoplasm Screening Using Stool DNA-based SDC2 and SFRP2 Methylation Test in China, a Multi-Center Study
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.
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. ;
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