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Progression of Gastroesophageal Reflux Disease and Barrett's Esophagus and the Creation of a Barrett's Registry
This study is currently recruiting participants.
Study NCT00574327   Information provided by Kansas City Veteran Affairs Medical Center
First Received: December 14, 2007   Last Updated: February 3, 2009   History of Changes

December 14, 2007
February 3, 2009
January 2006
 
The goal of this study is to follow GERD and BE pts prospectively for development of dysplasia and adenocarcinoma, to identify factors responsible for progression of GERD to BE to dysplasia and adenocarcinoma. [ Time Frame: 5 plus years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00574327 on ClinicalTrials.gov Archive Site
The secondary goal is to create a tissue and serum repository for future biomarker studies. [ Time Frame: 5 plus years ] [ Designated as safety issue: No ]
Same as current
 
Progression of Gastroesophageal Reflux Disease and Barrett's Esophagus and the Creation of a Barrett's Registry
A Prospective Study To Define The Role Of Various Factors In Development And Progression Of Gastroesophageal Reflux Disease (GERD) And Barrett's Esophagus And The Creation Of A Registry.

The purpose of this study is to determine or evaluate the risk factors such as smoking, family history etc. that cause esophageal cancer and to determine the genetic changes that lead to esophageal cancer. The investigators hypothesis is that systematic collection of data on the natural history of GERD and BE patients and risk factors for development of BE in patients with chronic GERD and progression of BE to dysplasia and adenocarcinoma will provide useful information to develop a decision model for risk stratification and risk reduction strategies in these patients.

As of June 11, 2009 148 patients have been enrolled at the Kansas City VA Medical Center.

Symptoms of gastroesophageal reflux are common. It affects at least 40% of the adult American population and 40 million American adults experience reflux symptoms on a regular basis. Gastroesophageal reflux disease (GERD) typically affects Caucasians and older males. It is a significant risk factor for development of Barrett's esophagus (BE) and esophageal adenocarcinoma. Approximately 10-15% of patients with chronic GERD are diagnosed with BE, a premalignant lesion for esophageal adenocarcinoma. Adenocarcinoma of the esophagus continues to be the most rapidly increasing incidence cancer in the United States. Based on studies evaluating screening/surveillance strategies, it is clear that it is imperative to identify risk factors that would target those patients with gastroesophageal reflux disease (GERD) and BE that may benefit from screening and surveillance strategies, yet also be practical and cost-effective. A better understanding of the events surrounding the development of BE in patients with chronic GERD, development of dysplastic changes in patients with BE and progression of BE to adenocarcinoma may ultimately help in identifying those patients at increased risk. Thus, our hypothesis is that systematic collection of data on the natural history of GERD and BE patients and risk factors for development of BE in patients with chronic GERD and progression of BE to dysplasia and adenocarcinoma will provide useful information to develop a decision model for risk stratification and risk reduction strategies in these patients. This model will be a useful tool leading to a reduction in overall health care costs.

The study will be conducted at the Kansas City Department of Veterans Affairs Medical Center. This is a prospective cohort study designed to analyze the epidemiologic and genetic factors relevant to development of BE in patients with GERD and its subsequent progression to dysplasia and adenocarcinoma. 1) The consenting patients as well as controls (2:1 ratio) will be asked to fill validated questionnaire on severity of GERD and food frequency. Data regarding medications, family history and social history will also be collected. 2) The endoscopy and pathology reports will be browsed for length of Barrett's esophagus confirmed by histology, length of hiatal hernia and presence of helicobacter pylori. 3) Serum samples from participating patients will be collected and frozen for measurements of insulin, glucose, lipid panel, CRP and adiponectin levels. Biopsies obtained from esophagus during endoscopy and blood samples would be frozen for future biomarker and cDNA microarray studies and histochemistry.

Approximately10-20% of the adult population has GERD and 0.5 to 2% of the adult population (1-4 million individuals) is estimated to have BE and it is a known precursor to esophageal adenocarcinoma. However, we are not yet able to reliably identify those individuals with GERD that are at risk for developing BE and with BE who are at high risk for progressing to esophageal adenocarcinoma. The identification of risk factors as the ultimate goal of this study will enable us to better identify the high-risk patients and provide early intervention and therapeutic strategies in a cost-effective manner.

 
Observational
Case Control, Prospective
  • Barrett's Esophagus
  • Gastroesophageal Reflux Disease
  • Esophageal Adenocarcinoma
 
  • Patients with documented BE with and without dysplasia (LGD or HGD) that will undergo surveillance endoscopies dictated by the grade of dysplasia.
  • Patients undergoing endoscopy for evaluation of GERD symptoms.
  • The control group would include patients undergoing upper endoscopy for reasons other than stated above, such as evaluation of iron deficiency anemia, weight loss, positive fecal occult blood, etc.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
3000
January 2012
 

Inclusion Criteria:

  • Patients with confirmed BE with and without dysplasia and patients with reflux disease (patients/cases); patients with other indicators for endoscopy such as anemia, weight loss, diarrhea, but without GERD and PE (controls).

Exclusion Criteria:

  • Patients with uncontrolled significant co-morbidities such as cardiovascular, pulmonary, renal, hepatic or metabolic diseases.
  • Presence of anticoagulation that would increase risk from biopsies
  • Patients unable to provide history
  • Patients with dyspepsia
Both
18 Years and older
Yes
Contact: April D Higbee, RN, BSN 816-861-4700 ext 57456 april.higbee@va.gov
United States
 
NCT00574327
Prateek Sharma, MD, Midwest Biomedical Research Foundation
PS0035
Midwest Biomedical Research Foundation
 
Principal Investigator: Prateek Sharma, MD Department of Veterans Affairs Medical Center of Kansas City
Kansas City Veteran Affairs Medical Center
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP