Fecal Screening Assay for Taiwanese Population

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer; Esophageal Cancer; Throat Cancer; Advanced Colorectal Neoplasms; Important Lower and Upper Gastrointestinal Tract Lesions
• Intervention / Treatment: Other: Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen test

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 Type: Observational
• Enrollment (Actual): 3172

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Our study will enroll consecutive subjects participating in the health check-up at National Taiwan University Hospital (Health Management Center), who will undergo a standard protocol, including I-FOBT, G-FOBT, HpSA, face-to-face interviews, blood chemistries, colonoscopy and EGD. Prior to the examination, a self-administered questionnaire will be used to collect information on participants' demographics, social habits, clinical symptoms, and medical/medication histories. To ensure that our study population was asymptomatic and the bleeders were occult, we excluded those who had overt GI symptoms and overt GI bleeding from analyses. During the same period, patients with screening detected GI tract cancers from other screening sites, such as throat cancer, esophageal cancer, gastric cancer, and colorectal cancers, will also be invited to participated in the study. This enrollment was based on insufficient GI cancer case number in the interim analyses based on a single screening site.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects undergoing bidirectional endoscopy and fecal tests; Subjects participating in the health check-up at National Taiwan University Hospital (Health Management Center)	Other: Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen test; Other Names: Fecal immunochemical test: OC-SENSOR; Eiken Chemical Co., Ltd, Tokyo, Japan; Guaiac fecal occult-blood test: Hemoccult SENSA Single Slides, Beckman Coulter Inc., USA; Helicobacter pylori stool antigen test: Easy One Step Test, Firstep Bioresearch, Inc., Taiwan
Patients with screening detected GI tract cancers; 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.	Other: Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen test; Other Names: Fecal immunochemical test: OC-SENSOR; Eiken Chemical Co., Ltd, Tokyo, Japan; Guaiac fecal occult-blood test: Hemoccult SENSA Single Slides, Beckman Coulter Inc., USA; Helicobacter pylori stool antigen test: Easy One Step Test, Firstep Bioresearch, Inc., Taiwan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Important Lower and Upper GI tract Lesions	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.	On the day of receving endoscopy

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yi-Chia Lee, MD.PhD, National Taiwan University Hospital

Publications and helpful links

General Publications

• Lee YC, Chiu HM, Chiang TH, Yen AM, Chiu SY, Chen SL, Fann JC, Yeh YP, Liao CS, Hu TH, Tu CH, Tseng PH, Chen CC, Chen MJ, Liou JM, Liao WC, Lai YP, Wang CP, Ko JY, Wang HP, Chiang H, Lin JT, Chen HH, Wu MS. Accuracy of faecal occult blood test and Helicobacter pylori stool antigen test for detection of upper gastrointestinal lesions. BMJ Open. 2013 Oct 30;3(10):e003989. doi: 10.1136/bmjopen-2013-003989.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: April 21, 2011
• First Submitted That Met QC Criteria: April 21, 2011
• First Posted (ESTIMATE): April 25, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 3, 2012
• Last Update Submitted That Met QC Criteria: November 30, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Mass screening; Fecal immunochemical test; Guaiac fecal occult blood test; Helicobacter pylori stool antigen test; Bidirectional endoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 201101016RC