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

NCT04515082 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 4800

Last updated 2020-08-18

No results posted yet for this study

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.

Conditions

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

Interventions

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

DIAGNOSTIC_TEST

FIT

Fecal immunochemical test

Sponsors & Collaborators

  • Changhai Hospital

    lead OTHER

Principal Investigators

  • Zhaoshen Li, MD · Changhai Hospital, Navy/Second Military Medical University

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2021-08-31
Completion
2021-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04515082 on ClinicalTrials.gov