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Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test

Sponsor
Kyung Hee University Hospital at Gangdong (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04304131
Collaborator
Genomictree, Inc. (Industry)
1,112
Enrollment
8
Locations
3
Arms
21.7
Anticipated Duration (Months)
139
Patients Per Site
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Earlytect Colon Cancer
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1112 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
Actual Study Start Date :
Jun 7, 2020
Actual Primary Completion Date :
Jan 10, 2022
Anticipated Study Completion Date :
Mar 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Colorectal cancer

Confirmed colorectal cancer under colonoscopy

Diagnostic Test: Earlytect Colon Cancer
A diagnostic device measuring syndecan 2 methylation status in stool DNA to detect colorectal cancer
Experimental: Colon polyp

Confirmed colorectal polyp under colonoscopy

Diagnostic Test: Earlytect Colon Cancer
A diagnostic device measuring syndecan 2 methylation status in stool DNA to detect colorectal cancer
Active Comparator: Healthy

Confirmed no cancer nor polyp under colonoscopy

Diagnostic Test: Earlytect Colon Cancer
A diagnostic device measuring syndecan 2 methylation status in stool DNA to detect colorectal cancer

Outcome Measures

Primary Outcome Measures

  1. SDC2 methylation in stool DNA [1 year]

    positive ratio of SDC2 methylation

  2. sensitivity and specificity of EarlyTect [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Busan Hangun Hospital Busan Korea, Republic of
2 Koo Hospital Daegu Korea, Republic of
3 Severance Hospital, Yonsei University College of Medicine Seoul Korea, Republic of 03722
4 Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine Seoul Korea, Republic of 05278
5 Dea Hang Hospital Seoul Korea, Republic of
6 Eunpyeong St. Mary's Hospital Seoul Korea, Republic of
7 Seoul Songdo Hospital Seoul Korea, Republic of
8 St. Vincent's Hospital, The Catholic University of Korea Suwon Korea, Republic of 16247

Sponsors and Collaborators

  • Kyung Hee University Hospital at Gangdong
  • Genomictree, Inc.

Investigators

  • Principal Investigator: Suk-Hwan Lee, MD, PhD, Kyung Hee University Hospital at Gangdong
  • Study Director: Chang Woo Kim, MD, PhD, Ajou University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suk-Hwan Lee, Professor, Kyung Hee University Hospital at Gangdong
ClinicalTrials.gov Identifier:
NCT04304131
Other Study ID Numbers:
  • Earlytect
First Posted:
Mar 11, 2020
Last Update Posted:
Mar 14, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Colorectal Neoplasms

Study Results

No Results Posted as of Mar 14, 2022