Screening Strategy for Gastric Cancer Prevention | NCT05387005

Studies
Screening Strategy for Gastric Cancer Prevention

NCT05387005

Sponsor

National Taiwan University Hospital

Status

Recruiting

Last Update Posted

Aug 17, 2025Actual

Enrollment

4,403Estimated

Phase

Not Applicable

Conditions

H. Pylori Infection

Interventions

UBT
HPSA
UBT and HPSA
Serology (two stage)

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 19, 2022Actual

Primary Completion Date

Apr 30, 2027Estimated

Completion Date

Apr 30, 2029Estimated

First Submitted Date

Apr 28, 2022

First Submission Date that Met QC Criteria

May 22, 2022

First Posted Date

May 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2025

Last Update Posted Date

Aug 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Initially, we planned to recruit 10,000 adults aged ≥20 years who had not previously undergone H. pylori screening or treatment. Eligible participants were to be randomly allocated in a 1:1:1:1 ratio to one of four groups, each receiving a different combination of diagnostic tests. However, a preliminary analysis led to a recalculation of the required sample size. Following the approval of an Institutional Review Board (IRB) amendment, enrollment was discontinued for Group B (HpSA method) and Group D (Two-stage screening method). The final number of participants enrolled in Group B and Group D was 852 and 851, respectively. Groups A (UBT method) and Group C (standard method) will continue to enroll participants through an additional 1:1 randomization until each group reaches a total of 1,350 participants.

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 Initially, the investigators will recruit adults with age of ≥20 years who have not received H. pylori screening or treatment. Eligible patients were 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) Standard method (Both C13 UBT and HpSA), (D) Two-stage screening method (serology screening only, and then C13 UBT for confirmation if serology test is positive). However, a preliminary analysis led to a recalculation of the required sample size. Following the approval of an Institutional Review Board (IRB) amendment, enrollment was discontinued for Group B and Group D. The final number of participants enrolled in Group B and Group D was 852 and 851, respectively. Groups A and Group C will continue to enroll participants through an additional 1:1 randomization until each group reaches a total of 1,350 participants.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4,403Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
UBT	Experimental	Diagnostic Test: UBT
HpSA	Experimental	Diagnostic Test: HPSA
Standard method	Experimental	Diagnostic Test: UBT and HPSA
Two-stage screening method	Experimental	Diagnostic Test: Serology (two stage)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UBT	Diagnostic Test	H. pylori diagnostic test: C13 urea breath test	UBT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection rates of H. pylori infection	The positivity rate of H. pylori infection between different study arms, respectively in ITT and PP analysis.	2-8 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.	2 weeks to 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults aged 20 years or older
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jyh-Ming Liou, MD,PhD	Contact	886-2-23123456	63541	jyhmingliou@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided