Multicentric Randomized Study of H. Pylori Eradication and Pepsinogen Testing for Prevention of Gastric Cancer Mortality (GISTAR)
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|ClinicalTrials.gov Identifier: NCT02047994|
Recruitment Status : Recruiting
First Posted : January 29, 2014
Last Update Posted : August 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Pylori Infections Atrophic Gastritis Gastric Cancer||Drug: Triple therapy||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicentric Randomized Study of H. Pylori Eradication and Pepsinogen Testing for Prevention of Gastric Cancer Mortality|
|Actual Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 2033|
|Estimated Study Completion Date :||December 2035|
Experimental: Group 1:Triple therapy
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
Participants who are positive with Helicobacter pylori in Group1 will receive triple therapy.
No Intervention: Group 2: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.
- Gastric cancer mortality [ Time Frame: 15 years ]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.
- Gastric cancer incidence [ Time Frame: 15 years ]The difference in gastric cancer incidence between Group 1 and Group 2 will be investigated
- All-cause mortality [ Time Frame: 15 years ]The all-cause mortality difference between Group 1 and Group 2 will also be investigated.
- Incidence of- and mortality from other medical conditions [ Time Frame: 15 years ]The impact of H. pylori eradication on selected medical conditions potentially associated with the infection (e.g. obesity, inflammatory bowel disease, dementia, circulatory diseases and esophageal diseases) will be explored.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02047994
|Contact: Rolando Herrero, MD, PhD||+33 4 72 73 86 83||HerreroR@iarc.fr|
|Contact: Marcis Leja, MD, PhD||+37 1 29 49 75 firstname.lastname@example.org|
|Institute of Clinical and Preventive Medicine, University of Latvia||Recruiting|
|Riga, Latvia, LV-1050|
|Contact: Marcis Leja, MD, PhD +37 1 29 49 75 00 email@example.com|
|Principal Investigator: Marcis Leja, MD, PhD|
|Principal Investigator:||Marcis Leja, MD, PhD||Associate Professor and Vice-dean, Institute of Clinical and Preventive Medicine, University of Latvia|
|Principal Investigator:||Rolando Herrero, MD, PhD||Head, Prevention and Implementation Group, International Agency for Research on Cancer|