Fecal Screening Assay for Taiwanese Population

NCT ID: NCT01341197

Last Updated: 2012-12-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3172 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-11-30

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.

Conditions

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

Keywords

Fecal immunochemical test; Guaiac fecal occult blood test; Helicobacter pylori stool antigen test; Mass screening; Bidirectional endoscopy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects undergoing bidirectional endoscopy and fecal tests

Subjects participating in the health check-up at National Taiwan University Hospital (Health Management Center)

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

Intervention Type: OTHER

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.

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

Intervention Type: OTHER

Interventions

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

Intervention Type: OTHER

Other Intervention 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

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi-Chia Lee, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 24176798 (View on PubMed)

Other Identifiers

201101016RC

Identifier Type: -

Identifier Source: org_study_id