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Multiple Screening Methods for the Detection of Chinese Colorectal Advanced Adenomatous Polyps and Cancer

NCT03411707 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2022-05-06

No results posted yet for this study

Summary

The primary objective is to determine the sensitivity and specificity of two Colorectal Cancer (CRC) screening methods, including stool DNA test and blood mRNA test, for colorectal cancer in Chinese population, with colonoscopy as reference method. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

The secondary objective is to compare the performance of these two CRC screening methods to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

Conditions

Interventions

DIAGNOSTIC_TEST

Stool DNA test

Stool DNA test could detect specific gene methylation in stool DNA. Blood mRNA test could detect specific set of gene expression in blood.

Sponsors & Collaborators

  • Changhai Hospital

    collaborator OTHER

  • Tianjin Nankai Hospital

    collaborator OTHER

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Hongzhi Zou, MD, PhD · The Sixth Affiliated Hospital, Sun Yet-sen University

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-19
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • China

Study Locations

More Related Trials

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 NCT03411707 on ClinicalTrials.gov