Clinical trial · Observational
Fecal Screening Assay for Taiwanese Population
A Pan-detecting Assay Based on Stool Samples for Taiwanese Population
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Colorectal Neoplasms | Colorectal Neoplasm | CURATED_BROADER | 0.78 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Important Lower and Upper Gastrointestinal Tract Lesions | — | UNRESOLVED | — |
| Throat Cancer | Throat Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Subjects undergoing bidirectional endoscopy and fecal tests
- description
- Subjects participating in the health check-up at National Taiwan University Hospital (Health Management Center)
- interventionNames
- Other: Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen test
- label
- Patients with screening detected GI tract cancers
- description
- 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.
- interventionNames
- Other: Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen test
Primary outcomes (1)
- measure
- Important Lower and Upper GI tract Lesions
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLee 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 24176798