Status:

COMPLETED

Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test

Lead Sponsor:

Kyung Hee University Hospital at Gangdong

Collaborating Sponsors:

Genomictree, Inc.

Conditions:

Colorectal Cancer

Colon Polyp

Eligibility:

All Genders

12+ years

Phase:

NA

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 7 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 10 2022

Estimated Enrollment :

1210 Patients enrolled

Trial Details

Trial ID

NCT04304131

Start Date

June 7 2020

End Date

January 10 2022

Last Update

March 14 2023

Active Locations (8)

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Page 1 of 2 (8 locations)

1

Busan Hangun Hospital

Busan, South Korea

2

Koo Hospital

Daegu, South Korea

3

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea, 03722

4

Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine

Seoul, South Korea, 05278