About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Identify as Non-Hispanic White
History of gastric cancer
Known premalignant lesions of the stomach
History of upper endoscopy within 2 years
Trial design
Sequential
Treatments tested in this trial
Biopsy
Procedure/SurgeryUndergo tissue biopsy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Breath Test
Procedure/SurgeryUndergo H. pylori breath test
Esophagogastroduodenoscopy
Procedure/SurgeryUndergo EGD
Questionnaire Administration
Other interventionComplete questionnaires
Treatment groups
Trial outcomes
Primary outcomes
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).
Sponsors and contacts
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator