NCT04304131

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,210

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 7, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

1.6 years

First QC Date

March 9, 2020

Last Update Submit

March 12, 2023

Conditions

Colorectal CancerColon PolypHealthy

Outcome Measures

Primary Outcomes (2)

  • SDC2 methylation in stool DNA

    positive ratio of SDC2 methylation

    1 year

  • sensitivity and specificity of EarlyTect

    1 year

Study Arms (3)

Colorectal cancer

EXPERIMENTAL

Confirmed colorectal cancer under colonoscopy

Diagnostic Test: Earlytect Colon Cancer

Colon polyp

EXPERIMENTAL

Confirmed colorectal polyp under colonoscopy

Diagnostic Test: Earlytect Colon Cancer

Healthy

ACTIVE COMPARATOR

Confirmed no cancer nor polyp under colonoscopy

Diagnostic Test: Earlytect Colon Cancer

Interventions

Earlytect Colon CancerDIAGNOSTIC_TEST

A diagnostic device measuring syndecan 2 methylation status in stool DNA to detect colorectal cancer

Colon polypColorectal cancerHealthy

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Busan Hangun Hospital

Busan, South Korea

Location

Koo Hospital

Daegu, South Korea

Location

Severance Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

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

Seoul, 05278, South Korea

Location

Dea Hang Hospital

Seoul, South Korea

Location

Eunpyeong St. Mary's Hospital

Seoul, South Korea

Location

Seoul Songdo Hospital

Seoul, South Korea

Location

St. Vincent's Hospital, The Catholic University of Korea

Suwon, 16247, South Korea

Location

Related Publications (11)

  • Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.

    PMID: 21296855RESULT

  • Baylin SB, Ohm JE. Epigenetic gene silencing in cancer - a mechanism for early oncogenic pathway addiction? Nat Rev Cancer. 2006 Feb;6(2):107-16. doi: 10.1038/nrc1799.

    PMID: 16491070RESULT

  • Ushijima T. Detection and interpretation of altered methylation patterns in cancer cells. Nat Rev Cancer. 2005 Mar;5(3):223-31. doi: 10.1038/nrc1571.

    PMID: 15719030RESULT

  • Laird PW. The power and the promise of DNA methylation markers. Nat Rev Cancer. 2003 Apr;3(4):253-66. doi: 10.1038/nrc1045.

    PMID: 12671664RESULT

  • Oh T, Kim N, Moon Y, Kim MS, Hoehn BD, Park CH, Kim TS, Kim NK, Chung HC, An S. Genome-wide identification and validation of a novel methylation biomarker, SDC2, for blood-based detection of colorectal cancer. J Mol Diagn. 2013 Jul;15(4):498-507. doi: 10.1016/j.jmoldx.2013.03.004. Epub 2013 Jun 7.

    PMID: 23747112RESULT

  • Xue M, Lai SC, Xu ZP, Wang LJ. Noninvasive DNA methylation biomarkers in colorectal cancer: A systematic review. J Dig Dis. 2015 Dec;16(12):699-712. doi: 10.1111/1751-2980.12299.

    PMID: 26565661RESULT

  • Mansour H. Cell-free nucleic acids as noninvasive biomarkers for colorectal cancer detection. Front Genet. 2014 Aug 27;5:182. doi: 10.3389/fgene.2014.00182. eCollection 2014.

    PMID: 25221563RESULT

  • Oh TJ, Oh HI, Seo YY, Jeong D, Kim C, Kang HW, Han YD, Chung HC, Kim NK, An S. Feasibility of quantifying SDC2 methylation in stool DNA for early detection of colorectal cancer. Clin Epigenetics. 2017 Dec 4;9:126. doi: 10.1186/s13148-017-0426-3. eCollection 2017.

    PMID: 29225717RESULT

  • Han YD, Oh TJ, Chung TH, Jang HW, Kim YN, An S, Kim NK. Early detection of colorectal cancer based on presence of methylated syndecan-2 (SDC2) in stool DNA. Clin Epigenetics. 2019 Mar 15;11(1):51. doi: 10.1186/s13148-019-0642-0.

    PMID: 30876480RESULT

  • Kim CW, Kim H, Kim HR, Won DD, Nam WJ, Min BS, Oh TJ, An S, Lee SH. A Stool DNA-Based SDC2 Methylation Test for the Early Detection of Colorectal Cancer in an Asymptomatic, High-Risk Population: A Multicenter Prospective Randomized Trial. Am J Gastroenterol. 2025 Mar 1;120(3):614-622. doi: 10.14309/ajg.0000000000003044. Epub 2024 Aug 21.

    PMID: 39292188DERIVED

  • Kim CW, Kim H, Kim HR, Kye BH, Kim HJ, Min BS, Oh TJ, An S, Lee SH. Colorectal cancer screening using a stool DNA-based SDC2 methylation test: a multicenter, prospective trial. BMC Gastroenterol. 2021 Apr 15;21(1):173. doi: 10.1186/s12876-021-01759-9.

    PMID: 33858326DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Polyps

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesIntestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Suk-Hwan Lee, MD, PhD

    Kyung Hee University Hospital at Gangdong

    PRINCIPAL INVESTIGATOR

  • Chang Woo Kim, MD, PhD

    Ajou University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 11, 2020

Study Start

June 7, 2020

Primary Completion

January 10, 2022

Study Completion

January 10, 2022

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(8)