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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04515082
• Other study ID #: CHEC2020-033
• Status: Not yet recruiting
• Start date: August 2020
• Est. completion date: August 2021

Study information

• Verified date: August 2020
• Source: Changhai Hospital
• Contact: Zhaoshen Li, MD
• Phone: +86-21-25070552
• Email: zhaoshenlismmu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

This study is a multi-center diagnostic test led by the National Clinical Research Center for Digestive Disease (Shanghai) (Department of Gastroenterology, Changhai Hospital, Navy/Second Military Medical University), which is conducted at about 30 digestive endoscopy centers nationwide in China, with the expectation of including approximately 4,800 patients. Subjects willing to conduct colonoscopy examination will be asked to collect stool sample prior to bowl preparation for stool DNA test and commercially available FIT assay. The basic characteristics of subjects, bowel preparation method and quality, and related information of colonoscopy are recorded in detail. Colonoscopy and histopathologic examination are used as reference.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4800
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenomatous Polyps
• Advanced Adenoma
• Colorectal Cancer
• Colorectal Neoplasm
• Colorectal Neoplasms
• Neoplasms
• Polyps
• Serrated Polyp

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

References & Publications (7)

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. — View Citation

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. Epub 2007 Apr 5. — View Citation

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. — View Citation

Oberwalder M, Zitt M, Wöntner C, Fiegl H, Goebel G, Zitt M, Köhle O, Mühlmann G, Ofner D, Margreiter R, Müller HM. SFRP2 methylation in fecal DNA--a marker for colorectal polyps. Int J Colorectal Dis. 2008 Jan;23(1):15-9. Epub 2007 Jul 17. — View 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Through study completion, an average of 1 year
Secondary	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.	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.	Through study completion, an average of 1 year