The GAstric Precancerous Conditions Study

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT04191551
Status
Recruiting

Conditions

  • Atrophic Gastritis
  • Gastric Cancer
  • Helicobacter Pylori Infection
  • Intestinal Metaplasia of Gastric Mucosa

Eligibility Criteria

Sex
ALL
Age
35 Years - 84 Years
Healthy Volunteers
Not accepted

Study Details

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).

Key Dates

Start date
Jul 30, 2018
Status verified
Dec 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Precursor lesions
    Subjects with precursor lesions detected on endoscopy.

Primary Outcome Measure

Histologic Progression or Regression Assessed by OLGA Score [ Time Frame: at least 24 months after enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Robert J Huang, MD
650-725-0634

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