Ignite Creation Date:
2024-05-05 @ 10:32 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01130363
Status:
TERMINATED
Last Update Posted:
2012-07-02
First Post:
2010-05-21
Brief Title:
Fundic Gland Polyps and Proton Pump Inhibitor PPI Drugs
Sponsor:
Organization:
Columbia University
Study Design
Study Type:
OBSERVATIONAL
Expanded Access Type Individual:
None
Expanded Access Type Intermediate:
None
Expanded Access Type Treatment:
None
Patient Registry:
None
Target Duration:
None
Design Allocation:
Design Intervention Model:
Design Intervention Model Description:
Design Masking Description:
Bio Spec Retention:
SAMPLES_WITH_DNA
Bio Spec Description:
Blood draw A fasting serum gastrin FSG level will be obtained to evaluate for hypergastrinemia at a follow-up visit after EGD Approximately 4 ccs of blood is required As many patients have been on long term PPI therapy the FSG level is one method of determining whether the patient is on super-therapeutic levels of PPI which may need to be adjusted
Biopsy specimens Gastric fundic gland polyps found during endoscopy will have biopsies taken of the polyp adjacent normal gastric body or fundus and from the antrum
Histological evaluation of biopsy specimens Biopsies will be stained with HE as well as neuroendocrine cell markers to assess for the presence of ECL cell hyperplasia Paraffin-fixed tissue will be stored for future biological analysis This will only be done after all clinically relevant analyses are completed and only if adequate tissue remains
Enrollment Count:
23
Enrollment Type:
ACTUAL
Design Primary Purpose:
Design Masking:
Phases:
Observational Models:
| Name |
|---|
| Case-Control |
Time Perspective List:
Clinical Trial Statuses
| Name |
|---|
| 11235 |
Who Masked List: