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Ultra-sensitivity Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma and Colorectal Cancer

NCT04856423 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 6000

Last updated 2021-09-16

No results posted yet for this study

Summary

Early detecting and removing of colorectal advanced adenomas can reduce the incidence of colorectal cancer. Because of the less bleeding of advanced adenomas, sensitivities of the common used quantitative fecal immunochemical tests (qFITs) are unsatisfying. Ultra-sensitivity qFIT(us-qFIT) can determine extremely low fecal hemoglobin concentration compared with the common used qFIT. This study will prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenomas.

Conditions

  • Colorectal Neoplasm

Interventions

DIAGNOSTIC_TEST

The us-qFIT and colonoscopy with pathological examination

Detect fecal hemoglobin concentration by us-qFIT before colonoscopy, detect colon lesions using colonoscopy and pathological examination.

Sponsors & Collaborators

  • Shanghai Tongji Hospital, Tongji University School of Medicine

    collaborator OTHER

  • Tianjin Medical University General Hospital

    collaborator OTHER

  • Binzhou Medical University

    collaborator OTHER

  • Weihai Municipal Hospital

    collaborator OTHER

  • People's Hospital of Lixia District of Jinan

    collaborator UNKNOWN

  • Shandong University

    lead OTHER

Principal Investigators

  • Yanqing Li, PhD · Qilu Hospital, Shandong University

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2023-04-19
Completion
2023-06-30

Countries

  • China

Study Locations

More Related Trials

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 NCT04856423 on ClinicalTrials.gov