The GAstric Precancerous Conditions Study (GAPS)

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 intestinal metaplasia (GIM) is a precancerous change of the stomach which increases risk for subsequent gastric cancer multiple-fold.

The Gastric Precancerous Conditions Study (GAPS) is an observational study with two over-arching objectives: 1) improve the non-invasive identification of patients with GIM, and 2) develop biological markers to predict the subset of GIM which will progress onto gastric cancer.

To achieve Aim 1, a case-control study (N=300 pairs) matching cases of GIM with age-/gender-matched controls will be recruited form the population of subjects undergoing clinically-indicated endoscopy. Determination of gastric pathology will be made by two, independent gastrointestinal pathologists. At time of endoscopy, a detailed clinical questionnaire is administered by face-to-face interview. Saliva and blood is collected prior to endoscopy. At time of endoscopy, protocoled clinical biopsies (per Revised Sydney Protocol) as well as additional research specimens are collected. Scoring of GIM will be performed based on the Operative Link for GIM scoring system.

To achieve Aim 2, patients with histologically-confirmed GIM (N=300) will be followed longitudinally. Biennial endoscopic surveillance will be performed, with repeat biopsies, specimen collection, and histologic scoring. Progression of GIM will be defined as upstaging of GIM score, or development of either dysplasia or carcinoma on any biopsy.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Robert J Huang, MD; Phone Number: 650-725-0634; Email: rjhuang@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Robert J Huang, MD; Phone Number: 650-725-0634; Email: rjhuang@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

As above

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Gastric intestinal metaplasia; Subjects with histologically-confirmed intestinal metaplasia found during endoscopy with protocoled biopsies.
Controls; Subjects without intestinal metaplasia found during endoscopy with protocoled biopsies (age and sex matched to cases)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of intestinal metaplasia	Progression will be assessed using the Operative Link for Gastric Intestinal Metaplasia (Reference 1). This score reflects both the histologic severity as well as anatomic location of intestinal metaplasia. Scores range from 0 (no metaplasia) to 4 (severe metaplasia). It is believed that higher scores portend a higher risk for progression to cancer.	24 months following enrollment

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Joo Ha Hwang, MD, PhD, Stanford University; Principal Investigator: Robert J Huang, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2018
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2026

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis; Precancerous Conditions; Metaplasia; Gastritis, Atrophic
• Other Study ID Numbers: 45077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No