NCT04515082

Colorectal Cancer Screening Using Stool DNA-based SDC2 and SFRP2 Methylation Test in China

Colorectal Cancer and Advanced Precancerous Neoplasm Screening Using Stool DNA-based SDC2 and SFRP2 Methylation Test in China, a Multi-Center Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 4,800 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colorectal Neoplasm
• Colorectal Cancer
• Adenomatous Polyps
• Adenoma
• Advanced Adenoma
• Serrated Polyp

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Stool-based SDC2 and SFRP2 DNA methylation test	A diagnostic device measuring syndecan 2 (SDC2) and secreted frizzled-related protein 2 (SFRP2) methylation status in stool DNA to detect colorectal cancer
DIAGNOSTIC_TEST	FIT	Fecal immunochemical test

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2020-08-17
• Last updated: 2020-08-18