NCT04515082

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

August 13, 2020

Last Update Submit

August 15, 2020

Conditions

Colorectal NeoplasmColorectal CancerAdenomatous PolypsAdenomaAdvanced AdenomaSerrated Polyp

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

    Through study completion, an average of 1 year

Interventions

Stool-based SDC2 and SFRP2 DNA methylation testDIAGNOSTIC_TEST

A diagnostic device measuring syndecan 2 (SDC2) and secreted frizzled-related protein 2 (SFRP2) methylation status in stool DNA to detect colorectal cancer

Also known as: Colowell
FITDIAGNOSTIC_TEST

Fecal immunochemical test

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who referred to the outpatient and received colonoscopy.

You may qualify if:

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

You may not qualify if:

  • Unwilling to provide stool samples
  • Subject with contraindications for bowel preparation or colonoscopy
  • Subject with known colorectal polyps but not removed
  • Subject with inflammatory bowel disease
  • History of colonoscopy within 1 year
  • History of colorectal cancer
  • History of hereditary colorectal cancer syndrome (including polyposis)
  • Active lower gastrointestinal bleeding
  • Pregnancy
  • Subject taking anticoagulants such as aspirin and warfarin, or who have coagulopathy
  • Subject clinically highly suspected with gastrointestinal cancer
  • Other conditions deemed not suited for the study by investigators
  • Elimination Criteria:
  • Ask to withdraw from the study
  • Unable to get a stool sample
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 28619831BACKGROUND

  • 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.

    PMID: 29225717BACKGROUND

  • 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.

    PMID: 30876480BACKGROUND

  • 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.

    PMID: 17410438BACKGROUND

  • 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.

    PMID: 17639423BACKGROUND

  • 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.

    PMID: 18203283BACKGROUND

  • 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.

    PMID: 27721248BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Stool sample

MeSH Terms

Conditions

Colorectal NeoplasmsAdenomatous PolypsAdenoma

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Zhaoshen Li, MD

    Changhai Hospital, Navy/Second Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaoshen Li, MD

CONTACT

+86-21-25070552zhaoshenlismmu@gmail.com

Yu Bai, MD

CONTACT

+86-13564665324baiyu1998@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 17, 2020

Study Start

August 1, 2020

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

August 18, 2020

Record last verified: 2020-08