Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408220
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-01
Brief Title:
Risk Assessment Evaluation for Identifying Participants at High Risk for Stomach Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
My Stomach Health Project A Pilot Study to Evaluate the Feasibility of Stomach Cancer Risk Assessment for Early Detection and Secondary Prevention
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA033572 | NIH | City of Hope Medical Center | httpsreporternihgovquickSearchP30CA033572 |
| NCI-2024-03206 | REGISTRY | None | None |
| 23379 | OTHER | None | None |