The GAstric Precancerous Conditions Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04191551

Acronym

GAPS

Enrollment

600

Registered

2019-12-09

Start date

2018-07-30

Completion date

2028-06-30

Last updated

2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 84 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Histologic Progression or Regression Assessed by OLGA Score	at least 24 months after enrollment	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.
Histologic Progression or Regression Assessed by OLGIM Score	at least 24 months after enrollment	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.
Development of Dysplasia	at least 24 months after enrollment	The presence or absence of dysplasia will be assessed as an indicator of histologic progression.
Development of Carcinoma	at least 24 months after enrollment	The presence or absence of carcinoma will be assessed to evaluate disease progression.

Countries

United States

Contacts

Primary ContactRobert J Huang, MD

rjhuang@stanford.edu650-725-0634

Outcome results