Menu
Recruiting NCT06408220

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

No phase Interventional Gastric Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biopsy, Biospecimen Collection, Breath Test, Esophagogastroduodenoscopy.
Who it may be relevant to
Registry conditions: Gastric Carcinoma. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • City of Hope Medical Center — Duarte

Identifiers

NCT: NCT06408220 · 23379 · NCI-2024-03206 · 23379 · P30CA033572

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗