The primary objective is to compare the performance of Stool-based SDC2 DNA Methylation Test and commercially available Fecal Immunochemical Test(FIT) , on the detection rate of advanced adenomatous polyps and colorectal cancer in Chinese population. Subjects with positive results in either test will receive colonoscopy. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
A large cohort of participants will be asked to collect stool sample for either Stool-based SDC2 DNA Methylation Test or Fecal Immunochemical Test. Subjects who have positive results will undergo colonoscopy within 6 months. Representative histopathology slides from tissue biopsied or excised during colonoscopy and those from subsequent definitive surgery may be retrieved in order to be evaluated by pathologists to confirm the diagnosis and staging.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
50,000
Stool-based SDC2 DNA methylation test
Fecal immunochemical test
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGBeijing Cancer Hospital
Beijing, China
RECRUITINGPeking University People's Hospital
Beijing, China
RECRUITINGGuangzhou Center for Disease Control and Prevention
Guangzhou, China
RECRUITINGSecond Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
RECRUITINGChanghai Hospital
Shanghai, China
RECRUITINGShanghai Municipal Center for Disease Control and Prevention
Shanghai, China
RECRUITINGTianjin Nankai Hospital
Tianjin, China
RECRUITINGThe Detection Rate of Colorectal Polyps, Advanced Adenomatous Polyps and Cancer by Two Screening Methods
The stool-based SDC2 DNA methylation test CT values of 38 or less compared to beta-actin considered to be positive. Fecal immunochemical test values of more than 100 ng of hemoglobin per milliliter of buffer were considered as positive. An optical colonoscopy is used as diagnostic method. Lesions will be confirmed by histopathologic examination.
Time frame: One year
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