Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513331
Status:
COMPLETED
Last Update Posted:
2014-01-01
First Post:
2007-08-06
Brief Title:
Barretts Esophagus Gastroesophageal Reflux Disease
Sponsor:
Valley Health System
Organization:
Valley Health System
Study Overview
Official Title:
The Valley Hospital Center for Barretts Esophagus and Gastroesophageal Reflux Disease GERD
Status:
COMPLETED
Status Verified Date:
2013-12
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 is a study of Barretts Esophagus BE and Gastroesophageal Reflux Disease GERD It aims to look at the long term efficacy of evidence-based cutting edge diagnostic and therapeutic algorithms and techniques such as radiofrequency ablation endoscopic mucosal resection and surveillance endoscopy with biopsy Additionally biological analyses will be performed in hopes of identifying biomarkers associated with the progression of BE to esophageal cancer
Detailed Description:
Barretts esophagus BE is a known premalignant condition of the esophagus predisposing to the development of esophageal adenocarcinoma BE represents a change in the lining mucosa of the esophagus which is known to be produced as a result of chronic gastroesophageal reflux The current standard of care for patients with BE includes serial performance of upper endoscopy with multiple biopsies performed at designated time intervals However the emergence of new technologies for the management of this condition has made the care of these patients non-uniform and subject to biases of individual treating physicians
The protocol at The Valley Hospital and Blumenthal Cancer Center aims to standardize the management of patients with Barretts esophagus with and without dysplasia using evidence-based cutting edge diagnostic and therapeutic algorithms and techniques such as radiofrequency ablation endoscopic mucosal resection and surveillance endoscopy with biopsies If biopsies suggest the development of carcinoma or high grade dysplasia surgical removal of the esophagus is recommended This study aims to look at the long-term efficacy of these procedures In addition data regarding clinical outcomes will be collected as well as blood tissue and surgical specimens for proteomic analysis in hopes of identifying biomarkers associated with the progression of dysplasia to adenocarcinoma Although patients will ultimately make their own informed decisions regarding the management of their BE this protocol serves to unify physician recommendations and allows for the collection and interpretation of data
The protocol at The Valley Hospital and Blumenthal Cancer Center aims to standardize the management of patients with Barretts esophagus with and without dysplasia using evidence-based cutting edge diagnostic and therapeutic algorithms and techniques such as radiofrequency ablation endoscopic mucosal resection and surveillance endoscopy with biopsies If biopsies suggest the development of carcinoma or high grade dysplasia surgical removal of the esophagus is recommended This study aims to look at the long-term efficacy of these procedures In addition data regarding clinical outcomes will be collected as well as blood tissue and surgical specimens for proteomic analysis in hopes of identifying biomarkers associated with the progression of dysplasia to adenocarcinoma Although patients will ultimately make their own informed decisions regarding the management of their BE this protocol serves to unify physician recommendations and allows for the collection and interpretation of data
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