Gastric Cancer Precursor Lesions (GCPL) Study
Condition: Intestinal Metaplasia; Gastric Cancer
MeSH terms: Stomach Neoplasms; Metaplasia
Study type: Observational

Summary: 
      Background:

      Gastric cancer is a leading cause of cancer deaths around the world. This disease is a
      serious problem in places like East Asia, Central and South America, and Eastern Europe.
      Researchers want to study the causes of gastric cancer and its precursors. They want to
      reduce the number of people with stomach cancer.

      Objectives:

      To learn more about bacteria factors and other causes of gastric cancer. To study potential
      markers associated with precancerous gastric lesions (intestinal metaplasia).

      Eligibility:

      Adults ages 40-70 years at certain hospitals in Chile who:

      Are going to have upper gastrointestinal endoscopies

      OR have stomach cancer and need surgery

      Design:

      Participants will give gastric tissue samples.

      Some participants will donate a portion of the stomach tissue that is removed as part of
      their clinical care.

      Participants will give access to reports of their stomach exam. They will allow researchers
      to photograph the microscope slides of their tissue samples.

      Participants will answer questions. The topics of the questions include:

      Age, height, weight

      Education

      Habits including tobacco and alcohol

      Personal and family history of disease

      Reproductive history

      Diet

      Some participants will give blood, urine, saliva, and stool samples. Study staff will collect
      the blood. They will tell the participants how to collect the other samples themselves.
    

Detailed description: 
      The burden of gastric adenocarcinoma is unevenly distributed, with several Asian and Latin
      American countries having particularly high incidence rates. Although chronic infection with
      Helicobacter pylori is the primary cause of this cancer, environmental and host cofactors
      modify the course of infection and determine whether infected individuals develop cancer. Due
      to the lack of adequate screening strategies and consequent late diagnosis, trends in
      mortality are similar to incidence, making this neoplasia the third leading cause of cancer
      death worldwide. The International Agency for Research on Cancer predicts that there will be
      no reduction in gastric cancer cases until at least 2030 due to population growth and aging.
      H. pylori-related gastric carcinogenesis is a multi-step process and mucosal lesions of
      intestinal metaplasia (IM) and dysplasia confer increased risk of progression. Therefore,
      case-control studies of these premalignant lesions may provide insights into cancer etiology
      and inform risk stratification. In addition, biomarkers to identify high-risk individuals are
      needed for early detection and curative treatment. Accordingly, we propose a 3-year study of
      Chilean adults undergoing upper gastrointestinal endoscopy for clinical purposes to identify
      600 subjects with advanced premalignant lesions (i.e., incomplete-type IM, complete-type IM
      with extension to gastric corpus and dysplasia) for informative comparisons with 600 controls
      with non-atrophic gastritis, a benign histologic change apparent in most H. pylori infected
      individuals. As an additional case group, 100 individuals with newly diagnosed gastric cancer
      will be recruited from the same clinics. This multidisciplinary project will simultaneously
      evaluate bacterial, host and environmental factors towards a better understanding of gastric
      cancer etiology that may guide future efforts for prevention and control. We will explore
      risk factors that have been insufficiently studied, such as various hormones, H. pylori
      genomics, non- H. pylori gastric microbiota, and other parasitic infections. We will also
      evaluate potential noninvasive screening markers, including pepsinogens, hormones, miRNAs and
      DNA methylation. Results from this study may lead to improved management recommendations for
      individuals with advanced IM. Additionally, the resulting biobank of gastric tissue, blood,
      urine, saliva and stool will enable state-of-the-art molecular assays and serve as a resource
      for future research in this area.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients attending gastroenterology services.
      
Biospecimen description: 
      gastric tissue, serum, plasma, buffy coat, saliva, urine, and stool.
    
Keywords: Gastric Intestinal Metaplasia; Epidemiology; Risk stratification; Helicobacter pylori; Precancerous lesions; Gastric atrophy