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

NCT ID: NCT06408220

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-27
• Study Completion Date: 2026-10-09

Brief 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.

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.

Conditions

Gastric Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Part I (initial risk assessment)

Participants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline.

Group Type: EXPERIMENTAL

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood sample collection

Breath Test

Intervention Type: PROCEDURE

Undergo H. pylori breath test

Questionnaire Administration

Intervention Type: OTHER

Complete questionnaires

Part II, Cohort I (EGD, biopsy)

Participants may undergo EGD with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years.

Group Type: EXPERIMENTAL

Biopsy

Intervention Type: PROCEDURE

Undergo tissue biopsy

Esophagogastroduodenoscopy

Intervention Type: PROCEDURE

Undergo EGD

Questionnaire Administration

Intervention Type: OTHER

Complete questionnaires

Part II, Cohort II (questionnaires)

Participants complete questionnaires for re-assessment annually up to 3 years and may undergo EGD at year 2.

Group Type: ACTIVE_COMPARATOR

Esophagogastroduodenoscopy

Intervention Type: PROCEDURE

Undergo EGD

Questionnaire Administration

Intervention Type: OTHER

Complete questionnaires

Interventions

Biopsy

Undergo tissue biopsy

Intervention Type: PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Intervention Type: PROCEDURE

Breath Test

Undergo H. pylori breath test

Intervention Type: PROCEDURE

Esophagogastroduodenoscopy

Undergo EGD

Intervention Type: PROCEDURE

Questionnaire Administration

Complete questionnaires

Intervention Type: OTHER

Other Intervention Names

BIOPSY_TYPE; Bx; Biological Sample Collection; Biospecimen Collected; Specimen Collection; EGD

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanghee Woo

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope Medical Center

Duarte, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Yanghee Woo

Role: primary

yhwoo@coh.org

626-218-0220

Other Identifiers

NCI-2024-03206

Identifier Type: REGISTRY

Identifier Source: secondary_id

23379

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23379

Identifier Type: -

Identifier Source: org_study_id