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Risk Assessment Methods for Stomach Cancer

N/A
Recruiting
Led By Yanghee Woo
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: ≥ 40 years to ≤ 80 years
Be older than 18 years old
Must not have
History of gastric cancer
Known premalignant lesions of the stomach
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of screening up to 3 years
Awards & highlights

Summary

This trial aims to test different methods like breath testing, questionnaires, and endoscopies to find people at high risk of stomach cancer. Helicobacter pylori (H. pylori)

Who is the study for?
This trial is for individuals who may be at high risk of developing stomach cancer. It's particularly focused on those who might have an infection with H. pylori, a bacteria linked to stomach ulcers and cancer.
What is being tested?
The study tests the effectiveness of various methods like breath tests for H. pylori, questionnaires about health history, and endoscopies (a tube with a camera inserted through the mouth) to find people at high risk for stomach cancer.
What are the potential side effects?
Potential side effects include discomfort or pain from the biopsy during endoscopy, gagging or sore throat from the esophagogastroduodenoscopy procedure, and possible bloating or belching from the breath test.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had gastric cancer in the past.
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I have been diagnosed with precancerous stomach lesions.
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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of screening up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of screening up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of screening individuals found to be at high risk for gastric cancer (feasibility)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Part II, Cohort I (EGD, biopsy)Experimental Treatment3 Interventions
Participants may undergo EGD with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years.
Group II: Part I (initial risk assessment)Experimental Treatment3 Interventions
Participants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline.
Group III: Part II, Cohort II (questionnaires)Active Control2 Interventions
Participants complete questionnaires for re-assessment annually up to 3 years and may undergo EGD at year 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esophagogastroduodenoscopy
2017
Completed Phase 3
~980
Biospecimen Collection
2004
Completed Phase 3
~2020
Biopsy
2014
Completed Phase 4
~1090

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,297 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,841 Previous Clinical Trials
41,002,649 Total Patients Enrolled
Yanghee WooPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
52 Total Patients Enrolled
~160 spots leftby Oct 2026
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