Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing
1 other identifier
interventional
99,314
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Jan 2014
Longer than P75 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2012
CompletedFirst Posted
Study publicly available on registry
December 4, 2012
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedResults Posted
Study results publicly available
November 21, 2024
CompletedNovember 21, 2024
October 1, 2018
7 years
October 5, 2012
December 20, 2016
November 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Stomach Cancer
Number of incident stomach cancer The recruitment period of participants was from January 1, 2014 to September 27, 2018. Final follow-up occurred December 31, 2020. For outcome measurement, the average follow-up time of the study participants was 5.5 years.
5.5 years
Mortality of Stomach Cancer
Number of stomach cancer death The recruitment period of participants was from January 1, 2014 to September 27, 2018. Final follow-up occurred December 31, 2020. For outcome measurement, the average follow-up time of the study participants was 5.5 years.
5.5 years
Secondary Outcomes (2)
Mortality of Colorectal Cancer
5.5 years
Incidence of Colorectal Cancer
5.5 years
Other Outcomes (5)
Helicobacter Pylori Eradication Rate
5.5 years
Confirmatory Examination Referral Rate
5.5 years
Detection of Advanced Adenoma and Cancer
5.5 years
- +2 more other outcomes
Study Arms (6)
one-day sampling with one-year interval
EXPERIMENTALFIT one-day sampling with one-year interval
one-day sampling with two-year interval
ACTIVE COMPARATORFIT one-day sampling with two-year interval
two-day sampling with one-year interval
EXPERIMENTALFIT two-day sampling with one-year interval
two-day sampling with two-year interval
EXPERIMENTALFIT two-day sampling with two-year interval
Hp stool antigen (HpSA)+FIT
EXPERIMENTALHpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT
FIT only
ACTIVE COMPARATORHpSA + FIT compared with FIT alone
Interventions
Collect two stool samples in two separate days
Screening with one-year interval
One-day sampling
Screening with two-year interval
HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.
Eligibility Criteria
You may qualify if:
- to 69 years average-risk subjects for FIT
- to 69 years subjects for HpSA
You may not qualify if:
- Subjects who are unwilling to participate
- Subjects ineligible for colonoscopy (for the one-day vs two day FIT screening)
- Subjects with a history of total gastrectomy
- Pregnancy
- Subjects with severe illnesses
- Subjects with prior participation in the pilot program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 10002, Taiwan
Related Publications (2)
Lee 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: 39348147DERIVEDLee 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: 33444571DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Han-Mo CHIU
- Organization
- Department of Internal Medicine, National Taiwan University Hospita
Study Officials
- PRINCIPAL INVESTIGATOR
Han-Mo Chiu, M.D., Ph.D.
Department of Internal Medicine & Health Management Center
- PRINCIPAL INVESTIGATOR
Yi-Chia Lee, M.D., Ph.D.
National Taiwan University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2012
First Posted
December 4, 2012
Study Start
January 1, 2014
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
November 21, 2024
Results First Posted
November 21, 2024
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share