Fecal Screening Assay for Taiwanese Population

Completed

• 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

• Registration Number: NCT01341197
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-25
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-30
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3172

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects undergoing bidirectional endoscopy and fecal tests	Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen test	Subjects participating in the health check-up at National Taiwan University Hospital (Health Management Center)
Patients with screening detected GI tract cancers	Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen test	Patients with screening detected GI tract cancer, such as throat cancer, esophageal cancer, gastric cancer and colorectal cancers, from other screening sites in Taiwan and were referred to the National Taiwan University Hospital for confirmatory diagnosis and treatment.

Primary Outcome Measures

Name	Time	Method
Important Lower and Upper GI tract Lesions	On the day of receving endoscopy	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan