Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
All Genders
Healthy Volunteers
ID06408220

OUR Stomach Health Project: Pilot Study Evaluating Stomach Cancer Risk Assessment for Early Detection and Secondary Prevention

Led by City of Hope Medical Center · Updated on 2026-03-13

240

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

C

City of Hope Medical Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating various risk assessment methods to identify people at high risk for stomach cancer. This study focuses on tests such as Helicobacter pylori (H. pylori) breath testing, questionnaires, and endoscopies. H. pylori is a bacteria linked to stomach inflammation, ulcers, and may increase the risk of stomach cancer. The research aims to determine how well these assessments work in diverse ethnic populations and to explore community outreach feasibility for early detection and prevention of gastric cancer. Participants start with a baseline risk assessment that includes questionnaires, blood sample collection, and an H. pylori breath test. Those identified as high-risk join a group that may receive an esophagogastroduodenoscopy (EGD) with possible tissue biopsy within three months and complete annual questionnaires for up to three years. Participants not at high risk continue with annual questionnaires for three years and may have an EGD at year two. Throughout the study, participants undergo regular evaluations including questionnaires and medical tests to monitor their stomach health. The study tracks how many people are found to be at high risk for gastric cancer and follows participants annually for three years. This ongoing monitoring helps researchers understand risk factors and the usefulness of these assessments in early stomach cancer detection and prevention.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented informed consent from the participant or authorized representative
  • Age between 40 and 80 years
  • Identify as a racial minority: Asian, Hispanic, or Black American
  • Willing to provide blood samples and undergo upper endoscopy
Not Eligible

You will not qualify if you...

  • Identify as Non-Hispanic White
  • History of gastric cancer
  • Known premalignant lesions of the stomach
  • History of upper endoscopy within 2 years
  • Pregnant or nursing women of childbearing potential
  • Employees supervised directly or indirectly by the principal investigator, co-investigator, or study manager
  • Direct study team members

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) involving questionnaires, blood sample collection, and H. pylori breath test

Surveillance

Duration - Up to 3 years

Participants are assessed for gastric cancer risk factors and assigned to cohorts based on their risk level.

Annual questionnaire visits for up to 3 years

Diagnostic Evaluation

Duration - Within 3 months after screening

High-risk participants may undergo an upper endoscopy (EGD) with possible tissue biopsy within 3 months of baseline assessment to identify actionable diagnoses.

1 to 2 visits depending on biopsy and endoscopy procedures

Diagnostic Evaluation

Duration - At year 2

Non-high risk participants may undergo an upper endoscopy (EGD) at year 2 as part of ongoing assessment.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

City of Hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

SCREENING

Number of Arms

3

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