OUR Stomach Health Project: A Pilot Study to Evaluate the Feasibility of Stomach Cancer Risk Assessment for Early Detection and Secondary Prevention
Summary
This clinical trial evaluates the usefulness of various risk assessment tests, including Helicobacter pylori (H. pylori) breath testing, questionnaires, and endoscopies for identifying participants at high risk for stomach cancer. H. pylori is a bacteria that causes stomach inflammation and ulcers in the stomach. People with H. pylori infections may be more likely to develop cancer in the stomach. H. pylori breath testing can help identify the presence of H. pylori infection in a participant and help identify if the participant may be at a higher risk of developing stomach cancer. An endoscopy uses a thin, flexible lighted tube that is inserted inside the esophagus, stomach, and first part of the small intestine. This allows the doctor to see and look for abnormal areas that may need to be biopsied. Risk assessment including H. pylori evaluation, questionnaires, and endoscopies may help identify participants at high risk for stomach cancer and may be a useful screening tool for earlier stomach cancer diagnosis.
Detailed description
PRIMARY OBJECTIVE: I. To determine the feasibility of using community outreach and clinical assessment to identify persons at high risk for gastric cancer. SECONDARY OBJECTIVES: I. To determine the presence of gastric cancer (GC) associated risk factors amongst the diverse ethnic populations (in greater Orange and Los Angeles Counties). II. To determine the proportion of high-risk patients who are willing to undergo upper endoscopy. III. To identify actionable diagnoses on upper endoscopy of high-risk individuals. EXPLORATORY OBJECTIVE: I. To assess population-based understanding of gastric cancer. OUTLINE: PART I: Participants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline. PART II: High-risk participants are assigned to cohort I and non-high risk participants are assigned to cohort II. COHORT I: Participants may undergo esophagogastroduodenoscopy (EGD) with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years. COHORT II: Participants complete questionnaires for re-assessment annually up to 3 years and may undergo EGD at year 2. Participants are followed up annually for a total of 3 years.
Arms & interventions
- ProcedureBiopsy
Undergo tissue biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBreath Test
Undergo H. pylori breath test
- ProcedureEsophagogastroduodenoscopy
Undergo EGD
- OtherQuestionnaire Administration
Complete questionnaires
Outcome measures
Primary
Percentage of screening individuals found to be at high risk for gastric cancer (feasibility)
Study feasibility will be defined as ≥ 10% of screened individuals found to be at high risk for gastric cancer. The study will be successful if ≥ 10% of screened individuals (24 of ≤ 240) have a risk score of ≥ 12 or have signs/symptoms that have persisted for ≥ 1 month that are associated with gastric cancer. The reported results will include counts/proportions of screened individuals found to be at high risk for gastric cancer (≥ 12 risk score).
Time frame: At time of screening up to 3 years
Eligibility criteria
Study locations (1)
City of Hope Medical Center
Duarte, California, 91010