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

NCT06408220 | Recruiting DMC

• 3 other identifiers: 23379NCI-2024-03206P30CA033572
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Part I (initial risk assessment)

EXPERIMENTAL

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

Procedure: Biospecimen Collection; Procedure: Breath Test; Other: Questionnaire Administration

Part II, Cohort I (EGD, biopsy)

EXPERIMENTAL

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

Procedure: Biopsy; Procedure: Esophagogastroduodenoscopy; Other: Questionnaire Administration

Part II, Cohort II (questionnaires)

ACTIVE COMPARATOR

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

Procedure: Esophagogastroduodenoscopy; Other: Questionnaire Administration

Interventions

Biopsy PROCEDURE

Undergo tissue biopsy

Also known as: BIOPSY_TYPE, Bx

Part II, Cohort I (EGD, biopsy)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Part I (initial risk assessment)

Breath Test PROCEDURE

Undergo H. pylori breath test

Part I (initial risk assessment)

Esophagogastroduodenoscopy PROCEDURE

Undergo EGD

Also known as: EGD

Part II, Cohort I (EGD, biopsy); Part II, Cohort II (questionnaires)

Questionnaire Administration OTHER

Complete questionnaires

Part I (initial risk assessment); Part II, Cohort I (EGD, biopsy); Part II, Cohort II (questionnaires)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Biopsy; Specimen Handling; Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Minimally Invasive Surgical Procedures

Study Officials

• Yanghee Woo

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 10, 2024
• Study Start: June 27, 2024
• Primary Completion (Estimated): October 9, 2029
• Study Completion (Estimated): October 9, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)