Factors influencing participation in preventive interventions for gastric cancer: the results from the GISTAR study.
Mārcis Leja, Eva Cine, Inese Poļaka...
https://pubmed.ncbi.nlm.nih.gov/34519690Actively Recruiting
Phase 4
Age: 40Years - 64Years
All Genders
Healthy Volunteers
ID02047994
Multicentric Randomized Study of H. Pylori Eradication and Pepsinogen Testing for Prevention of Gastric Cancer Mortality
Led by International Agency for Research on Cancer · Updated on 2025-05-02
30000
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
I
International Agency for Research on Cancer
Lead Sponsor
U
University of Latvia
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate if screening for Helicobacter pylori (H. pylori) infection followed by treatment for those who test positive and endoscopic monitoring of individuals with signs of atrophic gastritis can reduce deaths from gastric cancer in middle-aged adults living in high-risk regions. The study is a large, multicenter randomized trial involving 30,000 participants aged 40 to 64 years from areas with high gastric cancer rates in Latvia, Belarus, and Russia. The goal is to determine the impact of these strategies on gastric cancer mortality over 15 years of follow-up. Participants will be randomly assigned to one of two groups. The first group will receive H. pylori screening through blood tests and pepsinogen testing, with those testing positive offered a 10-day triple therapy to eradicate H. pylori and those with atrophic gastritis undergoing endoscopy with biopsies and follow-up as needed. Breath samples will also be collected from this group for additional biomarker studies. The second group will receive usual care without intervention but will be offered fecal occult blood testing (FOBT) to detect other gastrointestinal issues. Positive FOBT results in both groups will lead to colonoscopy referrals. Throughout the study, participants will complete questionnaires and receive medical evaluations at enrollment. Follow-up will occur for at least 15 years, including telephone or other communications every 5 years to assess health outcomes, particularly gastric cancer incidence and mortality. Researchers will monitor differences in cancer rates and deaths between the groups, study biomarkers for atrophic gastritis, assess volatile markers in breath, and evaluate the effects of eradication on other health conditions. This long-term monitoring aims to identify effective prevention methods for gastric cancer in high-risk populations.
CONDITIONS
Brief Title
Multicentric Randomized Study of H. Pylori Eradication and Pepsinogen Testing for Prevention of Gastric Cancer Mortality
Who Can Participate
Age: 40Years - 64Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Men and women aged 40-64 at the time of signing the consent form
- Willingness to participate regardless of study group after understanding potential benefits and risks
- Signed consent form including acceptance of sample transport across borders if needed
- Good health as confirmed by physical exam and medical history at enrollment
You will not qualify if you...
- Personal history of gastric cancer
- Gastric surgery due to benign disease (except ulcer suturing and vagotomy)
- H. pylori eradication therapy within 12 months before enrollment
- Presence of alarm symptoms for digestive or other diseases
- Serious organic disease indicated by physical exam
- Serious co-morbid conditions with life expectancy under 5 years
- Factors limiting participation such as mobility issues
- Serious psychological or psychiatric conditions affecting understanding
- Low expected compliance with diagnostic or treatment procedures
- Expected loss to follow-up due to communication or travel issues
- Missing signed consent form
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for medical evaluation and informed consent
Treatment
Duration - 10 days for triple therapy; endoscopy and follow-up schedule varies according to clinical guidelines
Participants in Group 1 who test positive for Helicobacter pylori will receive triple therapy for eradication. Participants with serological evidence of atrophic gastritis will undergo upper endoscopy and further endoscopic follow-up according to guidelines. Participants in Group 2 will receive no intervention but will be offered medical evaluation and fecal occult blood testing as part of the study benefits.
1 baseline visit for H. pylori and pepsinogen testing; additional visits for endoscopy and treatment as needed
Long-term Monitoring
Duration - At least 15 years
All participants will be followed up for at least 15 years to collect information on medical conditions, especially gastric cancer and cause of death. Follow-up includes telephone or alternative communication every 5 years for outcome assessment.
Follow-up contact every 5 years (telephone or alternative communication)
Trial Site Locations
Total: 1 location
1
Institute of Clinical and Preventive Medicine, University of Latvia
Riga, Latvia, LV-1050
Actively Recruiting
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Research Team
M
Marcis Leja, MD, PhD
J
Jin Young Park, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Multicentric randomised study of Helicobacter pylori eradication and pepsinogen testing for prevention of gastric cancer mortality: the GISTAR study.
Marcis Leja, Jin Young Park, Raul Murillo...
https://pubmed.ncbi.nlm.nih.gov/28801429