RecruitingNot ApplicableNCT06408220

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

OUR Stomach Health Project: A Pilot Study to Evaluate the Feasibility of Stomach Cancer Risk Assessment for Early Detection and Secondary Prevention


Sponsor

City of Hope Medical Center

Enrollment

240 participants

Start Date

Jun 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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

Interventions

PROCEDUREBiopsy

Undergo tissue biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBreath Test

Undergo H. pylori breath test

PROCEDUREEsophagogastroduodenoscopy

Undergo EGD

OTHERQuestionnaire Administration

Complete questionnaires


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT06408220


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