Clinical trial NCT04191551: The GAstric Precancerous Conditions Study
Official title: The GAstric Precancerous Conditions Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Intestinal Metaplasia of Gastric Mucosa
Helicobacter Pylori Infection
Atrophic Gastritis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 600
Sex: ALL
Minimum age (years): 35
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As above

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).


Eligibility 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

Primary outcomes:
measure: Histologic Progression or Regression Assessed by OLGA Score
timeFrame: at least 24 months after enrollment
measure: Histologic Progression or Regression Assessed by OLGIM Score
timeFrame: at least 24 months after enrollment
measure: Development of Dysplasia
timeFrame: at least 24 months after enrollment
measure: Development of Carcinoma
timeFrame: at least 24 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Robert J Huang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Joo Ha Hwang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: