NCT04221854

Stool-based SDC2 DNA Methylation Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50,000 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Colorectal Cancer
• Colorectal Adenomatous Polyp
• Screening

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Stool-based SDC2 DNA methylation test	Stool-based SDC2 DNA methylation test
DIAGNOSTIC_TEST	Fecal immunochemical test	Fecal immunochemical test

Timeline

• Start date: 2020-01-06
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2020-01-09
• Last updated: 2020-02-18

Locations

8 sites across 1 country: China