Clinical trial · Interventional
Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing
Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing: a Population-based Randomized Study
NCT01741363CI-TRIAL-00082839completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
1. The abundant results from this trial will be helpful for assessing the feasibility of increasing stool sampling and shortening screening interval in population setting for lower and upper gastrointestinal tract lesions, their long-term effects, and the respective cost-effectiveness. 2. The study will evaluate the value of population-based screen and treatment for H. pylori infection when the HPSA is combined with the FIT.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stomach Disease | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FIT(Eiken OC-Sensor) One-day sampling | Other | — | UNRESOLVED |
| FIT(Eiken OC-Sensor) One-year interval | Other | — | UNRESOLVED |
| FIT(Eiken OC-Sensor) Two-day sampling | Other | — | UNRESOLVED |
| FIT(Eiken OC-Sensor) Two-year interval | Other | — | UNRESOLVED |
| FIT only | Other | — | UNRESOLVED |
| HpSA (Firstep Helicobacter pylori Antigen Rapid Test) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- one-day sampling with one-year interval
- description
- FIT one-day sampling with one-year interval
- interventionNames
- Other: FIT(Eiken OC-Sensor) One-year interval
- Other: FIT(Eiken OC-Sensor) One-day sampling
- type
- ACTIVE_COMPARATOR
- label
- one-day sampling with two-year interval
- description
- FIT one-day sampling with two-year interval
- interventionNames
- Other: FIT(Eiken OC-Sensor) One-day sampling
- Other: FIT(Eiken OC-Sensor) Two-year interval
- type
- EXPERIMENTAL
- label
- two-day sampling with one-year interval
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * 50 to 69 years average-risk subjects for FIT * 50 to 69 years subjects for HpSA Exclusion Criteria (for the FIT-based RCT): * Subjects who are unwilling to participate * Subjects ineligible for colonoscopy (for the one-day vs two day FIT screening) Exclusion Criteria (for the FIT+HPSA vs. FIT-only RCT) * Subjects with a history of total gastrectomy * Pregnancy * Subjects with severe illnesses * Subjects with prior participation in the pilot program
References
Publications (3)
- DERIVEDLee YC, Liu JH, Mulder DT, Yang JY, Chiang TH, Hsu WF, Chiu HM, Su WW, Chou KC, Chen SL, Fann JC, Chiu SY, Chuang SL, Chen YR, Chu TC, Chang MY, Chen ST, Hu TH, Fang YJ, Liou JM, Wu MS, Yeh YP, Hur C, Yen AM, Chen TH; Collaborators of the Taiwan Community-Based Integrated Screening Group. Cost-Effectiveness of Fecal Immunochemical Testing Alone vs Co-Testing With Helicobacter pylori Stool Antigen. JAMA. 2026 Jul 7;336(1):35-46. doi: 10.1001/jama.2026.6908. PMID 42223961
- DERIVEDLee YC, Chiang TH, Chiu HM, Su WW, Chou KC, Chen SL, Yen AM, Fann JC, Chiu SY, Chuang SL, Chen YR, Chen SD, Hu TH, Fang YJ, Wu MS, Chen TH, Yeh YP; Collaborators of Taiwan Community-based Integrated Screening Group. Screening for Helicobacter pylori to Prevent Gastric Cancer: A Pragmatic Randomized Clinical Trial. JAMA. 2024 Nov 19;332(19):1642-1651. doi: 10.1001/jama.2024.14887. PMID 39348147
- DERIVEDLee YC, Chiang TH, Chiu HM, Wu MS, Yeh YP, Hsiu-Hsi Chen T; Collaborators of the Taiwan Community-Based Integrated Screening Group. Community-Based Gastric Cancer Screening Coupled With a National Colorectal Cancer Screening Program: Baseline Results. Gastroenterology. 2021 May;160(6):2159-2161.e4. doi: 10.1053/j.gastro.2021.01.008. Epub 2021 Jan 11. No abstract available. PMID 33444571