N/A
N=99,314
Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing
Colorectal Cancer · Stomach Disease
Bottom Line
View on ClinicalTrials.gov: NCT01741363 ↗Enrolled (actual)
99,314
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Incidence of Stomach Cancer — 49; 59 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FIT(Eiken OC-Sensor) Two-day sampling (Other); FIT(Eiken OC-Sensor) One-year interval (Other); FIT(Eiken OC-Sensor) One-day sampling (Other); FIT(Eiken OC-Sensor) Two-year interval (Other); HpSA (Firstep Helicobacter pylori Antigen Rapid Test) (Other); FIT only (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- National Taiwan University Hospital
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Stomach Cancer |
49; 59 | — |
| PRIMARY Mortality of Stomach Cancer |
17; 23 | — |
| SECONDARY Mortality of Colorectal Cancer |
0; 0; 0; 0 | — |
| SECONDARY Incidence of Colorectal Cancer |
0; 0; 0; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01741363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.