Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161200
Status:
TERMINATED
Last Update Posted:
2009-12-11
First Post:
2005-09-08
Brief Title:
Esophageal Metaplasia Using a Novel Antibody Reversibility by Proton Pump Inhibitor
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Studies of Esophageal Metaplasia Using a Novel Antibody Reversibility of Columnar Metaplasia by Proton Pump Inhibitor
Status:
TERMINATED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this project we are trying to identify patients with the earliest signs of abnormality in the lining of the lower part of the food pipe or esophagus known as intestinal metaplasia IM also commonly called Barretts esophagus or Barretts Epithelium BE IM is sometimes difficult to diagnose by routine microscopic examination called histology We have developed a specific antibody a protein called immunoglobulin that specifically reacts with another partner protein if it exists Using this marker antibody called mAb Das-1 that has been patented US patent 5888743 we have shown that this marker can detect the abnormal changes in the distal esophagus before it is evident by histology IM usually develops in the face of long-term acid reflux from the stomach to the esophagus and causes the lining to change from the normal squamous type like that of skin to a type of lining normally seen in the small intestine and colon A subgroup of patients with IM may subsequently develop histologically evident Barretts Epithelium and a small percent of these patients may develop cancer of the esophagus Thus BE is considered as a pre-cancerous condition We already have an ongoing IRB for the portion of the project involving taking biopsies and performing the antibody staining to identify patients that react with the antibody but histologically negative for BE
Detailed Description:
We propose to study prospectively 68 patients who have been identified as positive with mAb DAS-1 immunostaining without histological evidence of specialized columnar epithelium True Barretts epithelium during routine endoscopy for dyspepsia or GERD symptoms These patients have been studied for initial screening for antibody staining under IRB protocol 1698 This number is based on the statistical analysis by Fishers exact test and has 90 power to detect a 30 negativity mAb Das-1 positive to negative at a p005 level During participation in IRB Protocol 1698 initial biopsy specimens were taken at
the squamo-columnar junction at least 2 sites - 12 oclock and 6 oclock positions and any other area with mucosal tongues of columnar epithelium
one from squamous epithelium at the distal esophagus to seek for the presence of esophagitis
one from antrum for the presence or absence of intestinal metaplasia of the stomach
and one from the gastric cardia
Following endoscopy and participation in IRB Protocol 1698 for the symptomatic patients who are not taking any proton pump inhibitor an H2 blocker Ranitidine ZantacÒ 150 mg twice daily will be started while the biopsy is being analyzed for histology and immunocytochemical stainings This is usually completed within 2 weeks Patients who showed positive reactivity in at least one biopsy sample taken during participation in Protocol 1698 with mAb Das-1 will be included in this study Patients who have been taking a proton pump inhibitor PPI for longer than 3 months preceeding study entry are not eligible to participate in this study Patients who have been taking proton pump inhibitors for 3 months or less at the time of the endoscopy and biopsy screening for mAb Das-1 may participate in this study 4 weeks after discontinuing the PPI ie a 4 week washout period
Patients will be randomized in a double-blinded fashion to receive either Pantoprazole 40 mg twice daily 34 patients or continued on Ranitidine 150 mg twice daily 34 patients for a total period of 6 months Pantoprazole and Ranitidine will be provided by Wyeth and the code will be kept by the pharmacy department at The Cancer Institute of New Jersey The drugs will be provided free of cost to the patients for the entire period Patients will be followed as out-patients at three-month intervals up to 6 months Patients will be advised to return any unused capsules during the follow-up visits The number of unused capsules as well as review of the patients medication diary will allow assessment of non-compliance Patients must be at least 75 compliant to remain on the study If any patient complains of persistent symptoms an effort will be made to provide relief with antacids as much as needed However if the patient is still symptomatic they will be taken off the study and unblinded If the patient is on Ranitidine they will be switched to open label Pantoprazole and will be followed and further treated in a routine manner If the patient is taking Pantoprazole pH monitoring to document acid reflux and planning of further management will be determined
All patients will have a follow-up endoscopy at 6 months with no cost to the patient This cost will be born by the grant received by Dr Das Additional endoscopy will be performed at 12 months and 24 months which is the current standard care procedure for surveillance in such patients Follow-up biopsy specimens will be taken the same way as the initial specimens and processed to see any changes in histology and mAb Das-1 reactivity
the squamo-columnar junction at least 2 sites - 12 oclock and 6 oclock positions and any other area with mucosal tongues of columnar epithelium
one from squamous epithelium at the distal esophagus to seek for the presence of esophagitis
one from antrum for the presence or absence of intestinal metaplasia of the stomach
and one from the gastric cardia
Following endoscopy and participation in IRB Protocol 1698 for the symptomatic patients who are not taking any proton pump inhibitor an H2 blocker Ranitidine ZantacÒ 150 mg twice daily will be started while the biopsy is being analyzed for histology and immunocytochemical stainings This is usually completed within 2 weeks Patients who showed positive reactivity in at least one biopsy sample taken during participation in Protocol 1698 with mAb Das-1 will be included in this study Patients who have been taking a proton pump inhibitor PPI for longer than 3 months preceeding study entry are not eligible to participate in this study Patients who have been taking proton pump inhibitors for 3 months or less at the time of the endoscopy and biopsy screening for mAb Das-1 may participate in this study 4 weeks after discontinuing the PPI ie a 4 week washout period
Patients will be randomized in a double-blinded fashion to receive either Pantoprazole 40 mg twice daily 34 patients or continued on Ranitidine 150 mg twice daily 34 patients for a total period of 6 months Pantoprazole and Ranitidine will be provided by Wyeth and the code will be kept by the pharmacy department at The Cancer Institute of New Jersey The drugs will be provided free of cost to the patients for the entire period Patients will be followed as out-patients at three-month intervals up to 6 months Patients will be advised to return any unused capsules during the follow-up visits The number of unused capsules as well as review of the patients medication diary will allow assessment of non-compliance Patients must be at least 75 compliant to remain on the study If any patient complains of persistent symptoms an effort will be made to provide relief with antacids as much as needed However if the patient is still symptomatic they will be taken off the study and unblinded If the patient is on Ranitidine they will be switched to open label Pantoprazole and will be followed and further treated in a routine manner If the patient is taking Pantoprazole pH monitoring to document acid reflux and planning of further management will be determined
All patients will have a follow-up endoscopy at 6 months with no cost to the patient This cost will be born by the grant received by Dr Das Additional endoscopy will be performed at 12 months and 24 months which is the current standard care procedure for surveillance in such patients Follow-up biopsy specimens will be taken the same way as the initial specimens and processed to see any changes in histology and mAb Das-1 reactivity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 120303 | OTHER | None | None |
| NIH 1R01 DK3618-01 | Other Identifier | CINJ | None |