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A Pan-detecting Assay Based on Stool Samples for Taiwanese Population

18 Years
95 Years
Not Enrolling
Advanced Colorectal Neoplasms, Throat Cancer, Esophageal Cancer, Gastric Cancer, Important Lower and Upper Gastrointestinal Tract Lesions

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Trial Information

A Pan-detecting Assay Based on Stool Samples for Taiwanese Population

Background and objective: 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.

Patients: Our study will enroll consecutive subjects participating in the health check-up at
National Taiwan University Hospital (Health Management Center), who will undergo I-FOBT,
G-FOBT, HpSA, colonoscopy and EGD. The diagnostic values of three fecal testing, alone or in
combination, will be respectively evaluated. knowing that subjects who were detected with
gastrointestinal tract cancers might be small based on one screening setting, we also
recruited patients who were detected with gastrointestinal tract cancers at other screening
sites and were referred to the National Taiwan University Hospital for confirmatory
diagnosis and treatment. They were also requested to complete the three fecal tests as well
as the bidirectional endoscopies; however, it should be noted that, in this group of
patients, those who completed only one of the bidirectional endoscopies were still eligible.

Our primary hypothesis was to test whether a guaiac-based test combined with an
immunochemical test could help differentiate occult bleeding in the upper gastrointestinal
tract from that in the lower gastrointestinal tract. As such a hypothesis would not be held,
we also evaluated an alternative choice based on Helicobacter pylori stool antigen test to
catching the upper gastrointestinal tract lesions.

Inclusion Criteria:

- subjects who received three fecal tests and receive confirmatory endoscopic diagnosis

Exclusion Criteria:

- subjects who had overt gastrointestinal bleeding (e.g., hematemesis, tarry stool,
melena, and hematochezia) that would normally push the patients to seek immediate
health care instead of participating in screening programs.

- subjects who do not receive the fecal tests

- subjects who do not receive the confirmatory endoscopic diagnosis

- subjects who had undergone gastrectomy or colectomy

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Important Lower and Upper GI tract Lesions

Outcome Description:

We define significant lower GI lesions as mass lesions (carcinoma and advanced adenoma), inflammation (erosive esophagitis, ulcer, and colitis), and vascular disorders (vascular ectasia and varices). Hyperplastic polyps are not considered significant lesions. Important upper GI lesions include cancer, esophageal varix, ulcer at least 0.5 cm in diameter with a perceptible depth, and angiodysplasia. Biopsies will be performed over any suspicious lesions for pathological confirmation. Reflux esophagitis with Los Angeles grade A or B severity is not considered significant.

Outcome Time Frame:

On the day of receving endoscopy

Safety Issue:


Principal Investigator

Yi-Chia Lee, MD.PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

March 2011

Completion Date:

November 2012

Related Keywords:

  • Advanced Colorectal Neoplasms
  • Throat Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Important Lower and Upper Gastrointestinal Tract Lesions
  • Fecal immunochemical test
  • Guaiac fecal occult blood test
  • Helicobacter pylori stool antigen test
  • Mass screening
  • Bidirectional endoscopy
  • Neoplasms
  • Colorectal Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms