Fecal Screening Assay for Taiwanese Population
A Pan-detecting Assay Based on Stool Samples for Taiwanese Population
1 other identifier
observational
3,172
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 21, 2011
CompletedFirst Posted
Study publicly available on registry
April 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedDecember 3, 2012
November 1, 2012
1.7 years
April 21, 2011
November 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Subjects undergoing bidirectional endoscopy and fecal tests
Subjects participating in the health check-up at National Taiwan University Hospital (Health Management Center)
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- subjects who received three fecal tests and receive confirmatory endoscopic diagnosis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan, 100, Taiwan
Related Publications (1)
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.
PMID: 24176798DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi-Chia Lee, MD.PhD
National Taiwan University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2011
First Posted
April 25, 2011
Study Start
March 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
December 3, 2012
Record last verified: 2012-11