The GAstric Precancerous Conditions Study

Recruiting

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

• Registration Number: NCT04191551
• Lead Sponsor: Stanford University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-30
• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-03
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States