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

Gastric Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06408220
• Other study ID #: 23379
• Secondary ID: NCI-2024-0320623
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2024
• Est. completion date: October 9, 2026

Study information

• Verified date: May 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 9, 2026
• Est. primary completion date: October 9, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Carcinoma
• Stomach Neoplasms

Intervention

Procedure:
• Biopsy
Undergo tissue biopsy
• Biospecimen Collection
Undergo blood sample collection
• Breath Test
Undergo H. pylori breath test
• Esophagogastroduodenoscopy
Undergo EGD

Other:
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of screening individuals found to be at high risk for gastric cancer (feasibility)	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).	At time of screening up to 3 years