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Trial record 18 of 21 for:    "Gastritis" | "Clarithromycin"

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
Sponsor:
Collaborators:
University of Latvia
Technion, Israel Institute of Technology
Karolinska Institutet
Academic Histology Laboratory (Latvia)
Vanderbilt University
Information provided by (Responsible Party):
International Agency for Research on Cancer

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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infections Atrophic Gastritis Gastric Cancer Drug: Triple therapy Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
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.

  • Esomeprazole 40 mg bid for 10 days
  • Clarithromycin 500 mg bid for 10 days
  • Amoxicillin 1000 mg bid for 10 days

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Gastric cancer incidence [ Time Frame: 15 years ]
    The difference in gastric cancer incidence between Group 1 and Group 2 will be investigated

  2. All-cause mortality [ Time Frame: 15 years ]
    The all-cause mortality difference between Group 1 and Group 2 will also be investigated.

  3. 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.



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Ages Eligible for Study:   40 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Personal history of gastric cancer (prevalent gastric cancer cases will not be revealed at the time of inclusion, and therefore will be included)
  • Gastric resections due to benign disease (ulcer suturing and vagotomy are accepted)
  • H. pylori eradication therapy within 12 months prior to inclusion (irrespective of the treatment result)
  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Rolando Herrero, MD, PhD +33 4 72 73 86 83 HerreroR@iarc.fr
Contact: Marcis Leja, MD, PhD +37 1 29 49 75 00 cei@latnet.lv

Locations
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Latvia
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    cei@latnet.lv   
Principal Investigator: Marcis Leja, MD, PhD         
Sponsors and Collaborators
International Agency for Research on Cancer
University of Latvia
Technion, Israel Institute of Technology
Karolinska Institutet
Academic Histology Laboratory (Latvia)
Vanderbilt University
Investigators
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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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: International Agency for Research on Cancer
ClinicalTrials.gov Identifier: NCT02047994     History of Changes
Other Study ID Numbers: 12-36
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

Keywords provided by International Agency for Research on Cancer:
Gastric cancer
Gastric cancer mortality
Helicobacter pylori treatment
Pepsinogen testing
Endoscopy
Volatile marker

Additional relevant MeSH terms:
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Gastritis
Gastritis, Atrophic
Stomach Neoplasms
Helicobacter Infections
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Gastroenteritis