Colorectal Cancer Clinical Trial
Official title:
Stool-based SDC2 DNA Methylation Test vs. Fecal Immunochemical Test on the Detection of Colorectal Advanced Adenomatous Polyps and Cancer in Chinese Population: A Multi-central Randomized Clinical Trial
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.
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