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Multitarget Stool FIT-DNA Study for Colorectal Cancer Early Screening in China

NCT04287335 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4758

Last updated 2020-12-08

No results posted yet for this study

Summary

The primary objective is to determine the diagnostic sensitivity and specificity of the newly developed multitarget FIT-DNA Colorectal Cancer (CRC) screening test (ColoClear) for detecting advanced neoplasia (including colorectal cancer and advanced adenomas) in high risk patients, using colonoscopy as the reference method. The secondary objective is to compare the screening performance of the multitarget FIT-DNA test with commercially available FIT (Fecal Immunochemical Test) assay in detecting advanced neoplasia.

Conditions

Interventions

DIAGNOSTIC_TEST

Multitarget stool FIT-DNA test - ColoClear

Multitarget stool FIT-DNA test

DIAGNOSTIC_TEST

FIT

fecal immunochemical test

PROCEDURE

Colonoscopy

diagnostic colonoscopy

Sponsors & Collaborators

  • New Horizon Health Technology Co., Ltd

    collaborator UNKNOWN

  • Beijing Mingze Technology Co., Ltd.

    collaborator UNKNOWN

  • Zhejiang University

    lead OTHER

Principal Investigators

  • Kefeng Ding, MD · Second Affiliated Hospital, School of Medicine, Zhejiang University

Eligibility

Min Age
40 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2019-12-08
Completion
2020-09-13

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 NCT04287335 on ClinicalTrials.gov