Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing
NCT ID: NCT01741363
Last Updated: 2024-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
99314 participants
INTERVENTIONAL
2014-01-01
2020-12-31
Brief Summary
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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.
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Detailed Description
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Nevertheless, the aforementioned advantages of FIT, missed neoplasms and interval cancer still exists under the current one-day stool sampling method with biennial screening interval, which might affect the effectiveness of overall screening program. Increase the number of stool samples or shortening of screening interval may be helpful for early detection of clinically significant neoplasms but it remains unclear whether such an approach may lower the screenee compliance or public participation. Moreover, its impact on the demand of confirmatory colonoscopy and cost-effectiveness of the whole screening program is still largely unknown and need to be further investigated.
In this study, we firstly aim to randomly allocate screening attendee to one of the following four arms: one-day sampling with annual screening, one-day sampling with biennial screening, two-day sampling with annual screening, and two-day sampling with biennial screening. Participation rate, positive rates of FIT, detection rate for neoplasms, positive predictive value, and long-term outcome including cancer incidence and mortality will be calculated and compared among four groups.
Secondly, in the Taiwanese population, which is a typical presentation of Asian populations, although the incidence of colorectal cancer is rapidly increasing, Helicobacter pylori-related upper gastrointestinal pathologies remain highly prevalent, which may imply that mass screening solely based on FIT could be insufficient as significant upper GI pathologies can be missed. Since the FIT does not predict upper GI pathologies, the adjunct of an「Helicobacter 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. Therefore, in the present study, we will also evaluate the value of simultaneous FIT and HpSA test in the community-based mass screening. We invited subjects in a randomized study to receive the FIT or the FIT plus HPSA. Those who are tested positive for HPSA will receive upper endoscopic examination and anti-H. pylori treatment. For the short-term indicators, we will evaluate the participation rate and diagnostic yield when the HPSA is added. For the long-term indicators, we will compare the incidence and mortality of gastric cancer as well as complicated peptic ulcers.
To summary, this study includes two randomized trials:
1. To make a comparison between one-day sampling with annual screening, one-day sampling with biennial screening, two-day sampling with annual screening, and two-day sampling with biennial screening using FIT;
2. To make a comparison between FIT plus HpSA and FIT alone for screening.
Finally, the cost-effectiveness analysis will be also conducted using previously established Markov model of CRC natural history and stomach diseases (such as dyspepsia, peptic ulcer disease, and gastric cancer) using the results ascertained from this trial. The primary outcomes were gastric cancer incidence and mortality rates as well as colorectal cancer incidence and mortality rates.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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one-day sampling with one-year interval
FIT one-day sampling with one-year interval
FIT(Eiken OC-Sensor) One-year interval
Screening with one-year interval
FIT(Eiken OC-Sensor) One-day sampling
One-day sampling
one-day sampling with two-year interval
FIT one-day sampling with two-year interval
FIT(Eiken OC-Sensor) One-day sampling
One-day sampling
FIT(Eiken OC-Sensor) Two-year interval
Screening with two-year interval
two-day sampling with one-year interval
FIT two-day sampling with one-year interval
FIT(Eiken OC-Sensor) Two-day sampling
Collect two stool samples in two separate days
FIT(Eiken OC-Sensor) One-year interval
Screening with one-year interval
two-day sampling with two-year interval
FIT two-day sampling with two-year interval
FIT(Eiken OC-Sensor) Two-day sampling
Collect two stool samples in two separate days
FIT(Eiken OC-Sensor) Two-year interval
Screening with two-year interval
Hp stool antigen (HpSA)+FIT
HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT
FIT(Eiken OC-Sensor) One-day sampling
One-day sampling
FIT(Eiken OC-Sensor) Two-year interval
Screening with two-year interval
HpSA (Firstep Helicobacter pylori Antigen Rapid Test)
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.
FIT only
HpSA + FIT compared with FIT alone
FIT(Eiken OC-Sensor) One-day sampling
One-day sampling
FIT(Eiken OC-Sensor) Two-year interval
Screening with two-year interval
FIT only
HPSA+FIT compared with FIT alone.
Interventions
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FIT(Eiken OC-Sensor) Two-day sampling
Collect two stool samples in two separate days
FIT(Eiken OC-Sensor) One-year interval
Screening with one-year interval
FIT(Eiken OC-Sensor) One-day sampling
One-day sampling
FIT(Eiken OC-Sensor) Two-year interval
Screening with two-year interval
HpSA (Firstep Helicobacter pylori Antigen Rapid Test)
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.
FIT only
HPSA+FIT compared with FIT alone.
Eligibility Criteria
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Inclusion Criteria
* 50 to 69 years subjects for HpSA
Exclusion Criteria
* 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
50 Years
69 Years
ALL
Yes
Sponsors
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Ministry of Health and Welfare, Taiwan
OTHER_GOV
National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Han-Mo Chiu, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine & Health Management Center
Yi-Chia Lee, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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References
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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.
Lee 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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201205030RIB
Identifier Type: -
Identifier Source: org_study_id
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