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The GAstric Precancerous Conditions Study
Recruiting
I'm InterestedTrial ID: NCT04191551
Purpose
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.
Official Title
The GAstric Precancerous Conditions Study
Stanford Investigator(s)
Joo Ha Hwang, MD, PhD
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Surgery
Robert Huang
Instructor, Medicine - Gastroenterology & Hepatology
Eligibility
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
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Robert J Huang, MD
650-725-0634