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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT04221854
Study type Interventional
Source Sixth Affiliated Hospital, Sun Yat-sen University
Contact Ping Lan, M.D., Ph.D.
Phone +86-13710316769
Email lanping@mail.sysu.edu.cn
Status Recruiting
Phase N/A
Start date January 6, 2020
Completion date December 31, 2021

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