Clinical trial NCT01341197: Fecal Screening Assay for Taiwanese Population
Official title: A Pan-detecting Assay Based on Stool Samples for Taiwanese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 3172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Important Lower and Upper GI tract Lesions
timeFrame: On the day of receving endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yi-Chia Lee, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.