Clinical trial · Observational

Colorectal Cancer Screening Using Stool DNA-based SDC2 and SFRP2 Methylation Test in China

Colorectal Cancer and Advanced Precancerous Neoplasm Screening Using Stool DNA-based SDC2 and SFRP2 Methylation Test in China, a Multi-Center Study

NCT04515082CI-TRIAL-00046671unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The primary objective is to determine sensitivity, specificity, positive predictive value and negative predictive value of a bi-target stool DNA testing (the methylation status of SDC2 and SFRP2) for colorectal cancer and advanced precancerous neoplasm(including advanced adenoma and advanced serrated lesions) screening, using colonoscopy as the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination. 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.

Conditions

Conditions (6)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Adenoma	Adenoma	ONTOLOGY_EXACT	0.98
Adenomatous Polyps	Adenomatous Polyp	ALIAS	0.90
Advanced Adenoma	Adenoma	CURATED_BROADER	0.78
Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80
Colorectal Neoplasm	Colorectal Neoplasm	ONTOLOGY_EXACT	0.98
Serrated Polyp	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
FIT	Diagnostic Test	—	UNRESOLVED
Stool-based SDC2 and SFRP2 DNA methylation test	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Sensitivity, specificity, positive predictive value and negative predictive value of bi-target stool DNA testing (the methylation status of SDC2 and SFRP2) with comparison to colonoscopy, both with respect to cancer and advanced precancerous neoplasm.
timeFrame
Through study completion, an average of 1 year
description
A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination. Advanced precancerous neoplasm includes both advanced adenoma and advanced serrated lesions. The DNA test includes the methylation status of SDC2 and SFRP2. The tests were processed independently of colonoscopy procedure.

Secondary outcomes (1)

measure
To compare the performance of the bi-target stool DNA testing to a commercially available FIT assay, both with respect to cancer and advanced precancerous neoplasm.
timeFrame
Through study completion, an average of 1 year
description
A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination. The stool DNA and FIT test were performed on the same stool sample.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 40 Years
Maximum age: 85 Years

Show eligibility criteria text

Inclusion Criteria:

1. Age between 40 to 85 years old, the gender is not limited
2. Willing to provide written consent
3. Able to provide stool sample

Exclusion Criteria:

1. Unwilling to provide stool samples
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

References

Publications (7)

BACKGROUNDNiu 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. PMID 28619831
BACKGROUNDOh 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 29225717
BACKGROUNDHan 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 30876480
BACKGROUNDHuang 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. PMID 17410438
BACKGROUNDOberwalder 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. PMID 17639423
BACKGROUNDWang 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. PMID 18203283
BACKGROUNDZhou 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.