Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05566899
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2022-07-05
Brief Title:
Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Primary Objective The Primary Objective of the Study is to Evaluate the Acceptability and Feasibility of EGD-SC
Status:
RECRUITING
Status Verified Date:
2023-09
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:
Screening esophagogastroduodenoscopy EGD provides three distinct opportunities to decrease gastric cancer GC morbidity and mortality has potential to discover cancer in early stages before the onset of symptoms leading to higher rates of survival Second premalignant lesions such as adenomatous polyps intestinal metaplasia and dysplasia can be discovered and removed with local resection akin to polypectomies during screening colonoscopies preventing the development of cancer Third EGD discovery and treatment of active Helicobacter pylori HP infection of the stomach provides an opportunity for primary prevention of GC
Detailed Description:
The primary objective of the study is to evaluate the acceptability and feasibility of EGD-SC
The secondary objectives are
1 Estimate Median added time needed for EGD at the time of routine screening colonoscopy
2 Estimate the frequencies of adverse events
3 Estimate the percentage of pre-cancer and cancerous lesions including H pylori infection chronic atrophic gastritis IM dysplasia and GC among this high GC risk population
4 Investigate whether high-risk racialethnicity groups have different likelihood of uptake of EGD and whether the likelihood is associated with patient beliefs attitudes and knowledge of GC perceptions of risk motivators and barriers and sociocultural factors as well as patient preference and satisfaction with EGD-SC
The secondary objectives are
1 Estimate Median added time needed for EGD at the time of routine screening colonoscopy
2 Estimate the frequencies of adverse events
3 Estimate the percentage of pre-cancer and cancerous lesions including H pylori infection chronic atrophic gastritis IM dysplasia and GC among this high GC risk population
4 Investigate whether high-risk racialethnicity groups have different likelihood of uptake of EGD and whether the likelihood is associated with patient beliefs attitudes and knowledge of GC perceptions of risk motivators and barriers and sociocultural factors as well as patient preference and satisfaction with EGD-SC
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Pro2022001252 | OTHER | Rutgers The State University of New Jersey | None |