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

Trial Title: Risk Assessment Evaluation for Identifying Participants at High Risk for Stomach Cancer

NCT ID: NCT06408220

Condition: Gastric Carcinoma

Conditions: Official terms:
Stomach Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Screening

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Biopsy
Description: Undergo tissue biopsy
Arm group label: Part II, Cohort I (EGD, biopsy)

Other name: BIOPSY_TYPE

Other name: Bx

Intervention type: Procedure
Intervention name: Biospecimen Collection
Description: Undergo blood sample collection
Arm group label: Part I (initial risk assessment)

Other name: Biological Sample Collection

Other name: Biospecimen Collected

Other name: Specimen Collection

Intervention type: Procedure
Intervention name: Breath Test
Description: Undergo H. pylori breath test
Arm group label: Part I (initial risk assessment)

Intervention type: Procedure
Intervention name: Esophagogastroduodenoscopy
Description: Undergo EGD
Arm group label: Part II, Cohort I (EGD, biopsy)
Arm group label: Part II, Cohort II (questionnaires)

Other name: EGD

Intervention type: Other
Intervention name: Questionnaire Administration
Description: Complete questionnaires
Arm group label: Part I (initial risk assessment)
Arm group label: Part II, Cohort I (EGD, biopsy)
Arm group label: Part II, Cohort II (questionnaires)

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.

Criteria for 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

Gender: All

Minimum age: 40 Years

Maximum age: 80 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: City of Hope Medical Center

Address:
City: Duarte
Zip: 91010
Country: United States

Status: Recruiting

Contact:
Last name: Yanghee Woo

Phone: 626-218-0220
Email: yhwoo@coh.org

Investigator:
Last name: Yanghee Woo
Email: Principal Investigator

Start date: June 27, 2024

Completion date: October 9, 2026

Lead sponsor:
Agency: City of Hope Medical Center
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: City of Hope Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06408220