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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06408220
Other study ID # 23379
Secondary ID NCI-2024-0320623
Status Recruiting
Phase N/A
First received
Last updated
Start date June 11, 2024
Est. completion date October 9, 2026

Study information

Verified date May 2024
Source City of Hope Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biopsy
Undergo tissue biopsy
Biospecimen Collection
Undergo blood sample collection
Breath Test
Undergo H. pylori breath test
Esophagogastroduodenoscopy
Undergo EGD
Other:
Questionnaire Administration
Complete questionnaires

Locations

Country Name City State
United States City of Hope Medical Center Duarte California

Sponsors (2)

Lead Sponsor Collaborator
City of Hope Medical Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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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