The GAstric Precancerous Conditions Study

NCT04191551 | Recruiting

• 2 other identifiers: IRB-45077NCI-2020-13776
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Histologic Progression or Regression Assessed by OLGA Score

  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.

  at least 24 months after enrollment

• Histologic Progression or Regression Assessed by OLGIM Score

  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.

  at least 24 months after enrollment

• Development of Dysplasia

  The presence or absence of dysplasia will be assessed as an indicator of histologic progression.

  at least 24 months after enrollment

• Development of Carcinoma

  The presence or absence of carcinoma will be assessed to evaluate disease progression.

  at least 24 months after enrollment

Study Arms (1)

Precursor lesions

Subjects with precursor lesions detected on endoscopy.

Eligibility Criteria

• Age: 35 Years - 84 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As above

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva Blood Gastric specimens

MeSH Terms

Conditions

Stomach Neoplasms; Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastritis; Gastroenteritis

Study Officials

• Robert J Huang, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Joo Ha Hwang, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert J Huang, MD

CONTACT

650-725-0634; rjhuang@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: July 30, 2018
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)