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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Carcinoma
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Questionnaire Administration; Procedure: Biopsy; Procedure: Esophagogastroduodenoscopy; Procedure: Breath Test

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Medical Center
      • Principal Investigator: Yanghee Woo
      • Contact: Yanghee Woo; Phone Number: 626-218-0220; Email: yhwoo@coh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Questionnaire Administration; Complete questionnaires; Procedure: Breath Test; Undergo H. pylori breath test
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.	Other: Questionnaire Administration; Complete questionnaires; Procedure: Biopsy; Undergo tissue biopsy; Other Names: Bx; BIOPSY_TYPE; Procedure: Esophagogastroduodenoscopy; Undergo EGD; Other Names: EGD
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.	Other: Questionnaire Administration; Complete questionnaires; Procedure: Esophagogastroduodenoscopy; Undergo EGD; Other Names: EGD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Yanghee Woo, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2024
• Primary Completion (Estimated): October 9, 2029
• Study Completion (Estimated): October 9, 2029

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cytological Techniques; Cytodiagnosis; Diagnostic Techniques, Surgical; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Biopsy; Specimen Handling; Endoscopy, Digestive System
• Other Study ID Numbers: 23379 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2024-03206 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No