An observational study in Gastric Cancer, Intestinal Metaplasia of Gastric Mucosa and Helicobacter Pylori Infection, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 35 Years to 84 Years. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Stanford University · Observational
Gastric cancer afflicts 27,000 Americans annually and carries a dismal prognosis. One reason for poor outcomes is late diagnosis, as the majority of gastric cancers in the United States are diagnosed at a relatively advanced stage where curative resection is unlikely. Gastric precursors (such as atrophic gastritis and intestinal metaplasia) are precancerous changes to the stomach mucosa which increases risk for subsequent gastric cancer.
The Gastric Precancerous Conditions Study (GAPS) is an observational study of patients at elevated risk for gastric cancer. Investigators seek to recruit patients from endoscopy unit of Stanford Health Care, a large academic network of hospitals and clinics serving Northern California. Investigators will recruit patients who are both symptomatic (e.g. dyspepsia) and asymptomatic (e.g. referred for screening), and individuals both with known precursor lesions (such as intestinal metaplasia) or at high risk for carrying precursor lesions. A component of the study is long-term follow-up of individuals with gastric precursors. This is to understand their risk factors for histologic progression and regression. During both index and subsequent endoscopies, the study team will collect biospecimens (e.g. blood, saliva, gastric tissue).
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 600 is above the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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As above
Inclusion Criteria: Subjects between the ages of 35 and 84, who are undergoing outpatient endoscopy for the following indications are eligible: abdominal pain, dyspepsia, iron deficiency anemia, Helicobacter assessment, surveillance of suspected or known intestinal metaplasia, evaluation for family history of gastric cancer
Exclusion Criteria:
Subjects with precursor lesions detected on endoscopy.
Histologic Progression or Regression Assessed by OLGA Score
Histologic progression or regression will be evaluated using the Operative Link on Gastritis Assessment (OLGA) score. This score stages the severity of atrophic gastritis based on histological findings.
Time frame: at least 24 months after enrollment
Histologic Progression or Regression Assessed by OLGIM Score
Histologic progression or regression will be assessed using the Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) score. This score stages the extent of intestinal metaplasia.
Time frame: at least 24 months after enrollment
Development of Dysplasia
The presence or absence of dysplasia will be assessed as an indicator of histologic progression.
Time frame: at least 24 months after enrollment
Development of Carcinoma
The presence or absence of carcinoma will be assessed to evaluate disease progression.
Time frame: at least 24 months after enrollment
Plan to share: Undecided
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