The GAstric Precancerous Conditions Study (GAPS)

Stanford University

Status: Enrolling

Conditions: Atrophic Gastritis; Gastric Cancer; Helicobacter Pylori Infection; Intestinal Metaplasia of Gastric Mucosa

Study type: Observational

Funder types: Other

Identifiers

NCT04191551

NCI-2020-13776 (Registry Identifier)

IRB-45077

Details and patient eligibility

About

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).

Enrollment: 600 estimated patients

Sex: All

Ages: 35 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

600 participants in 1 patient group

Precursor lesions

Description:

Subjects with precursor lesions detected on endoscopy.