NCT02047994

Brief Summary

Currently no ideal preventive modalities are available for reducing gastric-cancer caused mortality in organized population-based application. The primary objective of the study is to determine if H.pylori screening followed by eradication of positive subjects and endoscopic follow-up of those with serological evidence of atrophic gastritis reduces mortality from gastric cancer in middle-aged people in high-risk areas. The GISTAR study is a multicenter randomized study of H.pylori eradication and pepsinogen testing for prevention of gastric cancer mortality. Altogether 30.000 individuals aged 40-64 years will be enrolled, providing 90% study power to detect at least 35% reduction in gastric cancer mortality at 15 years of follow-up. Participants will be randomly allocated to one of two groups. In the active investigation/management group those positive for H.pylori will be offered eradication therapy and individuals with decreased pepsinogen I/II ratio will be invited for endoscopy. The control group will receive standard health care. The primary endpoint for this trial will be the mortality difference from gastric cancer between the two groups at 15 years or when enough cases accumulate to demonstrate a statistical difference. The study is expected to provide valuable information on the utility for reduction in gastric cancer mortality of: 1) H.pylori eradication in adults on a population-basis, including subjects who may already have pre-malignant lesions; and 2) pepsinogen testing in screening settings. A pilot study of 3,455 individuals prior to the main trial was conducted from October 2013 to December 2016.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for phase_4

Timeline
116mo left

Started Mar 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress58%
Mar 2013Dec 2035

Study Start

First participant enrolled

March 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
19.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2033

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

20.8 years

First QC Date

January 27, 2014

Last Update Submit

April 30, 2025

Conditions

Helicobacter Pylori InfectionsAtrophic GastritisGastric Cancer

Keywords

Gastric cancerGastric cancer mortalityHelicobacter pylori treatmentPepsinogen testingEndoscopyVolatile marker

Outcome Measures

Primary Outcomes (1)

  • Gastric cancer mortality

    The primary objective of the study is to determine if H. pylori screening followed by eradication of positive subjects and endoscopic follow-up of those with serological evidence of atrophic gastritis reduces mortality from gastric cancer in a high risk population among 40-64 years old subjects.

    15 years

Secondary Outcomes (3)

  • Gastric cancer incidence

    15 years

  • All-cause mortality

    15 years

  • Incidence of- and mortality from other medical conditions

    15 years

Study Arms (2)

Group 1:Triple therapy

EXPERIMENTAL

Among those assigned to Group 1, participants who are Helicobacter pylori positive will receive Triple therapy and/or upper endoscopy. Participants with serological evidence of atrophic gastritis will undergo upper endoscopy and further endoscopic follow-up. H. pylori positive individuals will be offered Helicobacter pylori eradication as appropriate, independently of the pepsinogen results. From subjects in this group, breath samples will also be collected for volatile markers study. In addition, fecal occult blood test (FOBT) will be offered to this group as a benefit to participate in the study.

Drug: Triple therapy

Group 2:No intervention

NO INTERVENTION

Those who assigned to Group 2 will receive no intervention and will be offered FOBT as a benefit of study participation. Any participants who show positive FOBT will be referred to colonoscopy. This will be the benefit to this group together with initial medical evaluation at the time of inclusion. During the follow-up period this group will be offered to consult a specialist when required due to clinical symptoms.

Interventions

Triple therapyDRUG

Participants who are positive with Helicobacter pylori in Group1 will receive triple therapy. * Esomeprazole 40 mg bid for 10 days * Clarithromycin 500 mg bid for 10 days * Amoxicillin 1000 mg bid for 10 days

Group 1:Triple therapy

Eligibility Criteria

Age40 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women aged 40-64 at the time of signing the consent form
  • Willingness to get involved in the study irrespective in which of the study arms (after detailed information on the potential benefits and risks that this study may confer)
  • The person has signed a consent form (including the acceptance of transporting the samples over the borders, as appropriate)
  • To be in good health, as determined by a physical examination and history performed by a study physician at enrolment

You may not qualify if:

  • Gastric resections due to benign disease (ulcer suturing and vagotomy are accepted)
  • Presence of alarm symptoms for digestive or any other diseases (detailed in the questionnaire or during the physician evaluation)
  • Pathological findings at physical investigation suggestive for a serious organic disease (physician evaluation)
  • Serious co-morbid condition with life expectancy less than 5 years (physician evaluation)
  • Factors otherwise limiting the participation according to the protocol conditions (problems of mobility, etc.)
  • Serious psychological conditions/psychiatric disease limiting the possibilities to understand the requirements for diagnostic and/or medical interventions (physician evaluation)
  • Low expectations on the compliance for the diagnostic work-up or treatment (physician evaluation)
  • Expected loss for the follow-up (e.g. lack of communication possibilities and data entry in the registries, expected travel abroad, etc.) (physician evaluation)
  • Signed consent form is not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Clinical and Preventive Medicine, University of Latvia

Riga, LV-1050, Latvia

RECRUITING

Related Publications (2)

  • Leja M, Cine E, Polaka I, Daugule I, Murillo R, Parshutin S, Razuka-Ebela D, Rotberga L, Anarkulova L, Krike P, Santare D, Tzivian L, Herrero R, Park JY. Factors influencing participation in preventive interventions for gastric cancer: the results from the GISTAR study. Eur J Cancer Prev. 2022 Mar 1;31(2):128-136. doi: 10.1097/CEJ.0000000000000682.

    PMID: 34519690DERIVED

  • Leja M, Park JY, Murillo R, Liepniece-Karele I, Isajevs S, Kikuste I, Rudzite D, Krike P, Parshutin S, Polaka I, Kirsners A, Santare D, Folkmanis V, Daugule I, Plummer M, Herrero R. Multicentric randomised study of Helicobacter pylori eradication and pepsinogen testing for prevention of gastric cancer mortality: the GISTAR study. BMJ Open. 2017 Aug 11;7(8):e016999. doi: 10.1136/bmjopen-2017-016999.

    PMID: 28801429DERIVED

Related Links

MeSH Terms

Conditions

Gastritis, AtrophicStomach Neoplasms

Condition Hierarchy (Ancestors)

GastritisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Marcis Leja, MD, PhD

    Professor, Institute of Clinical and Preventive Medicine, University of Latvia

    PRINCIPAL INVESTIGATOR

  • Jin Young Park, PhD

    Early Detection, Prevention and Infections Branch, International Agency for Research on Cancer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcis Leja, MD, PhD

CONTACT

+37 1 29 49 75 00marcis.leja@lu.lv

Jin Young Park, PhD

CONTACT

+33 4 72 73 81 63parkjy@iarc.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2014

First Posted

January 29, 2014

Study Start

March 1, 2013

Primary Completion (Estimated)

December 1, 2033

Study Completion (Estimated)

December 1, 2035

Last Updated

May 2, 2025

Record last verified: 2025-04

Locations

LA(1)