Gastric Carcinoma Clinical Trial
Official title:
My Stomach Health Project: A Pilot Study to Evaluate the Feasibility of Stomach Cancer Risk Assessment for Early Detection and Secondary Prevention
Verified date | May 2024 |
Source | City of Hope Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | October 9, 2026 |
Est. primary completion date | October 9, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | 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 employee who is under the direct/indirect supervision of the principal investigator (PI)/a coinvestigator/the study manager - A direct study team member |
Country | Name | City | State |
---|---|---|---|
United States | City of Hope Medical Center | Duarte | California |
Lead Sponsor | Collaborator |
---|---|
City of Hope Medical Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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). | At time of screening up to 3 years |
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