Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT04191551

Conditions

Gastric Cancer

Intestinal Metaplasia of Gastric Mucosa

Helicobacter Pylori Infection

Atrophic Gastritis

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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).

Conditions

Gastric Cancer

Intestinal Metaplasia of Gastric Mucosa

Helicobacter Pylori Infection

Atrophic Gastritis

Study ID

NCT04191551

Start date

Jul 30, 2018

Status verified date

Dec, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

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:

  • Cannot give consent
  • Have history of gastric surgery
  • Have history of solid tumor or bone marrow transplant
  • Platelet Count < 70 or international normalized ratio > 1.5

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

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 ]
  • Histologic Progression or Regression Assessed by OLGIM Score [ Time Frame: at least 24 months after enrollment ]
  • Development of Dysplasia [ Time Frame: at least 24 months after enrollment ]
  • Development of Carcinoma [ Time Frame: at least 24 months after enrollment ]

Central Contacts and Locations

Central contacts

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

More Information

Sponsor

Stanford University

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-12-16.