Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test

March 12, 2023 updated by: Suk-Hwan Lee, Kyung Hee University Hospital at Gangdong
A study of colorectal cancer screening using stool DNA-based SDC2 methylation test

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Busan Hangun Hospital
      • Daegu, Korea, Republic of
        • Koo Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University College of Medicine
      • Seoul, Korea, Republic of, 05278
        • Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine
      • Seoul, Korea, Republic of
        • Dea Hang Hospital
      • Seoul, Korea, Republic of
        • Eunpyeong ST. Mary's Hospital
      • Seoul, Korea, Republic of
        • Seoul Songdo Hospital
      • Suwon, Korea, Republic of, 16247
        • St. Vincent's Hospital, The Catholic University of Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SDC2 methylation in stool DNA
Time Frame: 1 year
positive ratio of SDC2 methylation
1 year
sensitivity and specificity of EarlyTect
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyung Hee University Hospital at Gangdong

Collaborators

Genomictree, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2020

Primary Completion (Actual)

January 10, 2022

Study Completion (Actual)

January 10, 2022

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 12, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Earlytect

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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