Screening Strategy for Gastric Cancer Prevention

May 24, 2022 updated by: National Taiwan University Hospital

Identification of the Optimal Screening Strategy for Gastric Cancer Prevention

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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:

  1. Detection rate of H. pylori infection
  2. To compare the compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups.
  3. To assess the diagnostic accuracy of these tests.
  4. To verify the compliance(/adherence) and feasibility of this two-stage screening method
  5. Long-term Outcomes: To assess the risk reduction of gastric cancer

Study Type

Interventional

Enrollment (Anticipated)

10000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UBT
Diagnostic test: UBT
H. pylori diagnostic test: C13 urea breath test
Experimental: HpSA
Diagnostic test: HPSA
H. pylori diagnostic test: H. pylori stool antigen test
Experimental: Both
Diagnostic test: UBT and HPSA
H. pylori diagnostic tests: H. pylori serology test, C13 urea breath test
Experimental: Two-stage screening method
Diagnostic test: Serology (two stage)
H. pylori diagnostic test: H. pylori serology test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rates of H. pylori infection
Time Frame: 2-3 years
The positivity rate of H. pylori infection between different study arms, respectively in ITT and PP analysis.
2-3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups
Time Frame: 2-3 years
Completion rates of the study (from enrollment to the diagnosis of H. pylori; from enrollment to the treatment of H. pylori infection.
2-3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 30, 2022

Primary Completion (Anticipated)

March 31, 2025

Study Completion (Anticipated)

March 31, 2026

Study Registration Dates

First Submitted

April 28, 2022

First Submitted That Met QC Criteria

May 22, 2022

First Posted (Actual)

May 24, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202203064RINC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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