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Trial record 40 of 1598 for:    veterans affairs medical center

Progression of Gastroesophageal Reflux Disease and Barrett's Esophagus and the Creation of a Barrett's Registry

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ClinicalTrials.gov Identifier: NCT00574327
Recruitment Status : Recruiting
First Posted : December 17, 2007
Last Update Posted : December 3, 2018
Sponsor:
Collaborator:
Kansas City Veteran Affairs Medical Center
Information provided by (Responsible Party):
PRATEEK SHARMA, Midwest Biomedical Research Foundation

Tracking Information
First Submitted Date December 14, 2007
First Posted Date December 17, 2007
Last Update Posted Date December 3, 2018
Study Start Date January 2006
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 14, 2007)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00574327 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 14, 2007)
The secondary goal is to create a tissue and serum repository for future biomarker studies. [ Time Frame: 5 plus years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Progression of Gastroesophageal Reflux Disease and Barrett's Esophagus and the Creation of a Barrett's Registry
Official Title 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.
Brief Summary

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 March 17, 2011, 585 patients have consented at the Kansas City VA Medical Center.

Detailed Description

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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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 will be frozen for future biomarker and cDNA microarray studies and histochemistry.
Sampling Method Non-Probability Sample
Study Population All patients must be eligible for care at the Kansas City VA Medical Center. Those presenting to the Kansas City VA endoscopy laboratory for their "standard BE surveillance" endoscopy. Patients with a history of BE will be identified and contacted from the existing databank. Patients with newly diagnosed BE in the endoscopy laboratory after their procedure is completed and biopsy results are available. Patients undergoing upper endoscopy for evaluation of GERD symptoms. Control group of patients undergoing upper endoscopy for any reason other than the ones stated above.
Condition
  • Barrett's Esophagus
  • Gastroesophageal Reflux Disease
  • Esophageal Adenocarcinoma
Intervention Not Provided
Study Groups/Cohorts
  • A- Barrett's Esophagus subjects
    Patients with documented Barrett's Esophagus with or without dysplasia (LGD or HGD) that will undergo surveillance endoscopies dictated by the grade of dysplasia.
  • B- gastroesophageal reflux subjects
    Patients undergoing endoscopy for evaluation of GERD symptoms.
  • C-subjects without BE or GERD
    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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 14, 2007)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2024
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

All patients must be eligible for care that the Kansas City VA Hospital where this study was approved for enrollment.

Inclusion Criteria:

  • Kansas City VA 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 comorbidities 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: April D Higbee, RN, BSN 816-861-4700 ext 57456 april.higbee@va.gov
Contact: Tracy B Shipe 816-861-4700 ext 57994 tracy.shipe@va.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00574327
Other Study ID Numbers PS0035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party PRATEEK SHARMA, Midwest Biomedical Research Foundation
Study Sponsor Midwest Biomedical Research Foundation
Collaborators Kansas City Veteran Affairs Medical Center
Investigators
Principal Investigator: Prateek Sharma, MD Department of Veterans Affairs Medical Center of Kansas City
PRS Account Midwest Biomedical Research Foundation
Verification Date November 2018