OUR Stomach Health Project: A Pilot Study to Evaluate the Feasibility of Stomach Cancer Risk Assessment for Early Detection and Secondary Prevention
City of Hope Medical Center
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.
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 gas…
Eligibility
- Age range
- 40–80 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Age: ≥ 40 years to ≤ 80 years * Identify as a racial minority either Asian, Hispanic, or Black American * Willingness to: * Provide blood samples and undergo upper endoscopy Exclusion Criteria: * Identify as Non-Hispanic White * History of gastric cancer * Known premalignant lesions of the stomach * History of upper endoscopy within 2 years * Women of childbearing potential: Pregnant/ nursing * An empl…
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
Location
- City of Hope Medical CenterDuarte, California