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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-03206 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 23379 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I (initial risk assessment) | Experimental | Participants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline. |
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| Part II, Cohort I (EGD, biopsy) | Experimental | Participants may undergo EGD with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years. |
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| Part II, Cohort II (questionnaires) | Active Comparator | Participants complete questionnaires for re-assessment annually up to 3 years and may undergo EGD at year 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy | Procedure | Undergo tissue biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Documented informed consent of the participant and/or legally authorized representative
Age: ≥ 40 years to ≤ 80 years
Identify as a racial minority either Asian, Hispanic, or Black American
Willingness to:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanghee Woo | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Recruiting | Duarte | California | 91010 | United States |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D016145 | Endoscopy, Digestive System |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Biospecimen Collection | Procedure | Undergo blood sample collection |
|
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| Breath Test | Procedure | Undergo H. pylori breath test |
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| Esophagogastroduodenoscopy | Procedure | Undergo EGD |
|
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| Questionnaire Administration | Other | Complete questionnaires |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D003933 | Diagnosis |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003938 | Diagnostic Techniques, Digestive System |
| D004724 | Endoscopy |
| D013505 | Digestive System Surgical Procedures |
| D019060 | Minimally Invasive Surgical Procedures |