Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test

Kyung Hee University

Status: Completed

Conditions: Healthy; Colon Polyp; Colorectal Cancer

Treatments: Diagnostic Test: Earlytect Colon Cancer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04304131

Earlytect

Details and patient eligibility

About

A study of colorectal cancer screening using stool DNA-based SDC2 methylation test

Enrollment: 1,210 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient who agreed the clinical trial and signed informed consent
• High risk patient for colorectal cancer (family history of colorectal cancer, history of adenomatous polyp excision, inflammatory bowel disease > 15 years, or history of hereditary colorectal cancer)
• Patient who scheduled to receive colonoscopy
• Stool > 20g before bowel preparation for colonoscopy

Exclusion criteria

• No high risk patient under 60 years
• History of colorectal cancer
• Stool < 20g or sample after bowel preparation
• Diarrhea or liquid stool which cannot be evaluated
• Patient who is judged as not suitable for clinical trial including a psychiatric disorder by a physician

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,210 participants in 3 patient groups

Colorectal cancer

Experimental group

Description:

Confirmed colorectal cancer under colonoscopy

Treatment:

Diagnostic Test: Earlytect Colon Cancer

Colon polyp

Experimental group

Description:

Confirmed colorectal polyp under colonoscopy

Treatment:

Diagnostic Test: Earlytect Colon Cancer

Healthy

Active Comparator group

Description:

Confirmed no cancer nor polyp under colonoscopy

Treatment:

Diagnostic Test: Earlytect Colon Cancer