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NCT Number: NCT06408220

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

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.

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Key information

Conditions

Gastric Carcinoma Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

Location status: Recruiting

Location contact

Yanghee Woo

CONTACT

[email protected]

626-218-0220

Yanghee Woo

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy

Procedure

Undergo tissue biopsy

Other names: BIOPSY_TYPE, Bx

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Breath Test

Procedure

Undergo H. pylori breath test

Esophagogastroduodenoscopy

Procedure

Undergo EGD

Other names: EGD

Questionnaire Administration

Other

Complete questionnaires

Primary outcomes

  1. Percentage of screening individuals found to be at high risk for gastric cancer (feasibility)

    Time frame: At time of screening up to 3 years

    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).

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
May 10, 2024
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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