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Screening Strategy for Gastric Cancer Prevention

Primary Purpose

H. Pylori Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
UBT
HPSA
UBT and HPSA
Serology (two stage)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for H. Pylori Infection focused on measuring H. pylori, screening

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 10,000 adults of ≥20 years
  • Never screened and treated for H. pylori infection

Exclusion Criteria:

  • Ever undergone gastrectomy
  • Patients with gastric cancer
  • Have been screened or tested for H. pylori infection
  • Ever received H. pylori eradication therapy
  • Have taken proton pump inhibitor within two weeks
  • Have taken antibiotics within two weeks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    UBT

    HpSA

    Both

    Two-stage screening method

    Arm Description

    Outcomes

    Primary Outcome Measures

    Detection rates of H. pylori infection
    The positivity rate of H. pylori infection between different study arms, respectively in ITT and PP analysis.

    Secondary Outcome Measures

    The compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups
    Completion rates of the study (from enrollment to the diagnosis of H. pylori; from enrollment to the treatment of H. pylori infection.

    Full Information

    First Posted
    April 28, 2022
    Last Updated
    May 24, 2022
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05387005
    Brief Title
    Screening Strategy for Gastric Cancer Prevention
    Official Title
    Identification of the Optimal Screening Strategy for Gastric Cancer Prevention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 30, 2022 (Anticipated)
    Primary Completion Date
    March 31, 2025 (Anticipated)
    Study Completion Date
    March 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    There are still some unsolved questions regarding population-based screening program for H. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies. A prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of diagnostic tests in a population-based H. pylori screening and gastric cancer prevention program. The investigators will recruit 10,000 adults with age of ≥20 years who have not received H. pylori screening or treatment. Eligible patients will be randomly 1:1:1:1 allocated to four groups with different combination tests.
    Detailed Description
    Background: There are still some unsolved questions regarding population-based screening program for H. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies. Objective: A prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of C13 UBT and HpSA in a population-based H. pylori screening and gastric cancer prevention program. Methods：Open labeled, randomized controlled trial The investigators will recruit 10,000 adults with age of ≥20 years who have not received H. pylori screening or treatment. Eligible patients will be randomly 1:1:1:1 allocated to (A) The carbon-13 urea breath test (C13 UBT), (B) H. pylori stool antigen test (Vstrip® HpSA), (C) Both C13 UBT and HpSA, (D) Two-stage screening method (serology screening only, and then C13 UBT for confirmation if serology test is positive). Outcome analysis: Detection rate of H. pylori infection To compare the compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups. To assess the diagnostic accuracy of these tests. To verify the compliance(/adherence) and feasibility of this two-stage screening method Long-term Outcomes: To assess the risk reduction of gastric cancer

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    H. Pylori Infection
    Keywords
    H. pylori, screening

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    UBT
    Arm Type
    Experimental
    Arm Title
    HpSA
    Arm Type
    Experimental
    Arm Title
    Both
    Arm Type
    Experimental
    Arm Title
    Two-stage screening method
    Arm Type
    Experimental
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    UBT
    Intervention Description
    H. pylori diagnostic test: C13 urea breath test
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    HPSA
    Intervention Description
    H. pylori diagnostic test: H. pylori stool antigen test
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    UBT and HPSA
    Intervention Description
    H. pylori diagnostic tests: H. pylori serology test, C13 urea breath test
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Serology (two stage)
    Intervention Description
    H. pylori diagnostic test: H. pylori serology test
    Primary Outcome Measure Information:
    Title
    Detection rates of H. pylori infection
    Description
    The positivity rate of H. pylori infection between different study arms, respectively in ITT and PP analysis.
    Time Frame
    2-3 years
    Secondary Outcome Measure Information:
    Title
    The compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups
    Description
    Completion rates of the study (from enrollment to the diagnosis of H. pylori; from enrollment to the treatment of H. pylori infection.
    Time Frame
    2-3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 10,000 adults of ≥20 years Never screened and treated for H. pylori infection Exclusion Criteria: Ever undergone gastrectomy Patients with gastric cancer Have been screened or tested for H. pylori infection Ever received H. pylori eradication therapy Have taken proton pump inhibitor within two weeks Have taken antibiotics within two weeks
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jyh-Ming Liou, MD,PhD
    Phone
    886-2-23123456
    Ext
    63541
    Email
    jyhmingliou@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Screening Strategy for Gastric Cancer Prevention

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