Risk Assessment Evaluation for Identifying Participants at High Risk for Stomach Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06408220
Status
Recruiting
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Conditions

  • Gastric Carcinoma

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Breath Test — PROCEDURE
    Undergo H. pylori breath test
  • Esophagogastroduodenoscopy — PROCEDURE
    Undergo EGD
  • Questionnaire Administration — OTHER
    Complete questionnaires

Study Details

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.

Key Dates

Start date
Jun 27, 2024
Status verified
Mar 2026
Primary completion
Oct 9, 2029
Completion
Oct 9, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING

Arms

  • Experimental: Part I (initial risk assessment)
    Participants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline.
  • Experimental: Part II, Cohort I (EGD, biopsy)
    Participants may undergo EGD with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years.
  • Active Comparator: Part II, Cohort II (questionnaires)
    Participants complete questionnaires for re-assessment annually up to 3 years and may undergo EGD at year 2.

Primary Outcome Measure

Percentage of screening individuals found to be at high risk for gastric cancer (feasibility) [ Time Frame: At time of screening up to 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Yanghee Woo
[email protected]
626-218-0220
Yanghee Woo (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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