Colorectal CancerNCT04304131
Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
A study testing Earlytect Colon Cancer in people with Colorectal Cancer and Colon Polyp, run by Kyung Hee University Hospital at Gangdong at 8 sites in South Korea.
Trial summary
A study of colorectal cancer screening using stool DNA-based SDC2 methylation test Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Colorectal Cancer, Colon Polyp, Healthy
- What is being tested?
- Earlytect Colon Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,210 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 7 Jun 2020to 10 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Busan Hangun Hospital
Busan
Koo Hospital
Daegu
Severance Hospital, Yonsei University College of Medicine
Seoul, 03722
Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine
Seoul, 05278
Dea Hang Hospital
Seoul
Eunpyeong St. Mary's Hospital
Seoul
Seoul Songdo Hospital
Seoul
St. Vincent's Hospital, The Catholic University of Korea
Suwon, 16247
About this study
A study of colorectal cancer screening using stool DNA-based SDC2 methylation test
- Conditions
- Colorectal Cancer, Colon Polyp, Healthy
- Being tested
- Earlytect Colon Cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Earlytect Colon CancerDiagnostic test
A diagnostic device measuring syndecan 2 methylation status in stool DNA to detect colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer | Experimental | Confirmed colorectal cancer under colonoscopy Receives: Diagnostic Test: Earlytect Colon Cancer |
| Colon polyp | Experimental | Confirmed colorectal polyp under colonoscopy Receives: Diagnostic Test: Earlytect Colon Cancer |
| Healthy | Active comparator | Confirmed no cancer nor polyp under colonoscopy Receives: Diagnostic Test: Earlytect Colon Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
SDC2 methylation in stool DNA
positive ratio of SDC2 methylation
Measured: 1 year
sensitivity and specificity of EarlyTect
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start7 Jun 2020
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyung Hee University Hospital at Gangdong
- Sponsor type
- University, hospital or other
- Collaborators
- Genomictree, Inc.
- Responsible party
- Principal investigator, Suk-Hwan Lee, Kyung Hee University Hospital at Gangdong
- Investigators
- Suk-Hwan Lee, MD, PhD, Principal investigator, Kyung Hee University Hospital at GangdongChang Woo Kim, MD, PhD, Study director, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304131
- Sponsor's protocol ID
- Earlytect
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21296855Baylin 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.
PubMed 16491070Ushijima T. Detection and interpretation of altered methylation patterns in cancer cells. Nat Rev Cancer. 2005 Mar;5(3):223-31. doi: 10.1038/nrc1571.
PubMed 15719030Laird PW. The power and the promise of DNA methylation markers. Nat Rev Cancer. 2003 Apr;3(4):253-66. doi: 10.1038/nrc1045.
PubMed 12671664Oh 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.
PubMed 23747112Xue 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.
PubMed 26565661Mansour 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.
PubMed 25221563Oh 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.
PubMed 29225717Han 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.
PubMed 30876480Kim 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.
PubMed 39292188Kim 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.
PubMed 33858326
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
- ClinicalTrials.gov ID
- NCT04304131
- Acronym / sponsor ID
- Earlytect
- Conditions
- Colorectal Cancer, Colon Polyp, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,210 participants (actual)
- Lead sponsor
- Kyung Hee University Hospital at GangdongUniversity, hospital or other
- Collaborators
- Genomictree, Inc.
- Study start
- 7 Jun 2020 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study of colorectal cancer screening using stool DNA-based SDC2 methylation test
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer | Experimental | Diagnostic Test: Earlytect Colon CancerConfirmed colorectal cancer under colonoscopy |
| Colon polyp | Experimental | Diagnostic Test: Earlytect Colon CancerConfirmed colorectal polyp under colonoscopy |
| Healthy | Active comparator | Diagnostic Test: Earlytect Colon CancerConfirmed no cancer nor polyp under colonoscopy |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Earlytect Colon CancerA diagnostic device measuring syndecan 2 methylation status in stool DNA to detect colorectal cancer | Diagnostic test | Colon polyp, Colorectal cancer, Healthy |
Primary outcome
SDC2 methylation in stool DNA
Time frame: 1 year
positive ratio of SDC2 methylation
sensitivity and specificity of EarlyTect
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Results publication: PubMed 21296855Jemal 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.
- Results publication: PubMed 16491070Baylin 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.
- Results publication: PubMed 15719030Ushijima T. Detection and interpretation of altered methylation patterns in cancer cells. Nat Rev Cancer. 2005 Mar;5(3):223-31. doi: 10.1038/nrc1571.
- Results publication: PubMed 12671664Laird PW. The power and the promise of DNA methylation markers. Nat Rev Cancer. 2003 Apr;3(4):253-66. doi: 10.1038/nrc1045.
- Results publication: PubMed 23747112Oh 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.
- Results publication: PubMed 26565661Xue 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.
- Results publication: PubMed 25221563Mansour 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.
- Results publication: PubMed 29225717Oh 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.
- Results publication: PubMed 30876480Han 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.
- Derived from this study: PubMed 39292188Kim 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.
- Derived from this study: PubMed 33858326Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suk-Hwan Lee, MD, PhD principal investigator
Kyung Hee University Hospital at Gangdong
Chang Woo Kim, MD, PhD study director
Ajou University School of Medicine
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Earlytect Colon Cancer in people with Colorectal Cancer and Colon Polyp, run by Kyung Hee University Hospital at Gangdong at 8 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SDC2 methylation in stool DNA (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04304131, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023; AzTrials last refreshed its copy on 29 Oct 2026.