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The GAstric Precancerous Conditions Study (GAPS)

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ClinicalTrials.gov Identifier: NCT04191551
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Robert Huang, 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 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.


Condition or disease
Gastric Cancer Intestinal Metaplasia of Gastric Mucosa Helicobacter Pylori Infection Atrophic Gastritis

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The GAstric Precancerous Conditions Study
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  1. Progression of intestinal metaplasia [ Time Frame: 24 months following enrollment ]
    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.


Biospecimen Retention:   Samples With DNA
Saliva Blood Gastric specimens


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
As above
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04191551


Contacts
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Contact: Robert J Huang, MD 650-725-0634 rjhuang@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Robert J Huang, MD    650-725-0634    rjhuang@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Robert J Huang, MD Stanford University
Principal Investigator: Joo Ha Hwang, MD, PhD Stanford University
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Responsible Party: Robert Huang, Instructor of Medicine, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT04191551    
Other Study ID Numbers: 45077
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Precancerous Conditions
Gastritis
Gastritis, Atrophic
Metaplasia
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Gastroenteritis
Pathologic Processes