Colorectal Cancer Screening Using Stool DNA-based SDC2 and SFRP2 Methylation Test in China
NCT ID: NCT04515082
Last Updated: 2020-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
4800 participants
OBSERVATIONAL
2020-08-31
2021-08-31
Brief Summary
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The secondary objective is to compare the performance of the bi-target stool DNA testing to a commercially available fecal immunochemical test (FIT) assay, both with respect to cancer and advanced precancerous neoplasm. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Stool-based SDC2 and SFRP2 DNA methylation test
A diagnostic device measuring syndecan 2 (SDC2) and secreted frizzled-related protein 2 (SFRP2) methylation status in stool DNA to detect colorectal cancer
FIT
Fecal immunochemical test
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Willing to provide written consent
3. Able to provide stool sample
Exclusion Criteria
2. Subject with contraindications for bowel preparation or colonoscopy
3. Subject with known colorectal polyps but not removed
4. Subject with inflammatory bowel disease
5. History of colonoscopy within 1 year
6. History of colorectal cancer
7. History of hereditary colorectal cancer syndrome (including polyposis)
8. Active lower gastrointestinal bleeding
9. Pregnancy
10. Subject taking anticoagulants such as aspirin and warfarin, or who have coagulopathy
11. Subject clinically highly suspected with gastrointestinal cancer
12. Other conditions deemed not suited for the study by investigators
Elimination Criteria:
1. Ask to withdraw from the study
2. Unable to get a stool sample
3. Invalid stool samples to test
4. Poor or inadequate bowel preparation
5. Failed to complete the colonoscopy
40 Years
85 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Zhaoshen Li
MD, Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator, Clinical Professor
Principal Investigators
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Zhaoshen Li, MD
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital, Navy/Second Military Medical University
Central Contacts
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References
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Niu F, Wen J, Fu X, Li C, Zhao R, Wu S, Yu H, Liu X, Zhao X, Liu S, Wang X, Wang J, Zou H. Stool DNA Test of Methylated Syndecan-2 for the Early Detection of Colorectal Neoplasia. Cancer Epidemiol Biomarkers Prev. 2017 Sep;26(9):1411-1419. doi: 10.1158/1055-9965.EPI-17-0153. Epub 2017 Jun 15.
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.
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.
Huang Z, Li L, Wang J. Hypermethylation of SFRP2 as a potential marker for stool-based detection of colorectal cancer and precancerous lesions. Dig Dis Sci. 2007 Sep;52(9):2287-91. doi: 10.1007/s10620-007-9755-y. Epub 2007 Apr 5.
Oberwalder M, Zitt M, Wontner C, Fiegl H, Goebel G, Zitt M, Kohle O, Muhlmann G, Ofner D, Margreiter R, Muller HM. SFRP2 methylation in fecal DNA--a marker for colorectal polyps. Int J Colorectal Dis. 2008 Jan;23(1):15-9. doi: 10.1007/s00384-007-0355-2. Epub 2007 Jul 17.
Wang DR, Tang D. Hypermethylated SFRP2 gene in fecal DNA is a high potential biomarker for colorectal cancer noninvasive screening. World J Gastroenterol. 2008 Jan 28;14(4):524-31. doi: 10.3748/wjg.14.524.
Zhou Z, Zhang H, Lei Y. Diagnostic value of secreted frizzled-related protein 2 gene promoter hypermethylation in stool for colorectal cancer: A meta-analysis. J Cancer Res Ther. 2016 Oct;12(Supplement):30-33. doi: 10.4103/0973-1482.191625.
Other Identifiers
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CHEC2020-033
Identifier Type: -
Identifier Source: org_study_id
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