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Fecal Screening Assay for Taiwanese Population

NCT01341197 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3172

Last updated 2012-12-03

No results posted yet for this study

Summary

Fecal occult blood test (FOBT) is a convenient tool for the screening of asymptomatic gastrointestinal (GI) bleeding while 「guaiac-based fecal occult test (G-FOBT) 」 is increasingly replaced by the use of an 「immunochemical-based test (I-FOBT) 」 that reacts with human globin, a protein that is digested by upper GI enzymes and is specific for detecting lower GI bleeding. However, in Taiwan, although the incidence of colorectal cancer is rapidly increasing, Helicobacter pylori-related upper GI pathologies remain highly prevalent, which may imply that mass screening solely based on I-FOBT could be insufficient as significant upper GI pathologies can be missed. Since I-FOBT dose not predict upper GI pathologies, the adjuncts of G-FOBT and H. pylori stool-antigen test (HpSA) may be a potential candidate to realize a pan-detecting assay based on stool samples in a population in which both lower and upper GI lesions are equally prevalent.

Conditions

  • Advanced Colorectal Neoplasms
  • Throat Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Important Lower and Upper Gastrointestinal Tract Lesions

Interventions

OTHER

Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen test

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Yi-Chia Lee, MD.PhD · National Taiwan University Hospital

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Taiwan

Study Locations

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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 NCT01341197 on ClinicalTrials.gov