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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of screening up to 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1240

Biospecimen Collection

2004