Recruiting

Observational Study

Sponsor:

City of Hope Medical Center

Code:

NCT06408220

Conditions

Gastric Carcinoma

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Biopsy

Biospecimen Collection

Breath Test

Esophagogastroduodenoscopy

Questionnaire Administration

Study Details

Brief 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.

Conditions

Gastric Carcinoma

Study ID

NCT06408220

Start date

Jun 27, 2024

Status verified date

Mar, 2026

Completion date

Oct 9, 2029

Anticipated

Primary completion date

Oct 9, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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

Enrollment

240 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

Biopsy

Undergo tissue biopsy

Biospecimen Collection

Undergo blood sample collection

Breath Test

Undergo H. pylori breath test

Esophagogastroduodenoscopy

Undergo EGD

Questionnaire Administration

Complete questionnaires

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 ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Yanghee Woo

626-218-0220yhwoo@coh.org

Principal Investigator:

Yanghee Woo

More Information

Sponsor

City of Hope Medical Center

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-03-13.