Clinical trial NCT04304131: Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
Official title: Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Colon Polyp
Healthy
Lead sponsor: Kyung Hee University Hospital at Gangdong
Sponsor class: OTHER
Collaborators: name: Genomictree, Inc.
First posted: 2020-03-11
Enrollment: 1210
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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


Eligibility criteria: 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

Primary outcomes:
measure: SDC2 methylation in stool DNA
timeFrame: 1 year
measure: sensitivity and specificity of EarlyTect
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Busan Hangun Hospital
city: Daegu
country: Korea, Republic of
facility: Koo Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Dea Hang Hospital
city: Seoul
country: Korea, Republic of
facility: Eunpyeong St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Songdo Hospital
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital, The Catholic University of Korea
Study officials:
affiliation: Kyung Hee University Hospital at Gangdong
name: Suk-Hwan Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University School of Medicine
name: Chang Woo Kim, MD, PhD
role: STUDY_DIRECTOR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.