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
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.
|Condition or disease|
|Barrett's Esophagus Gastroesophageal Reflux Disease Esophageal Adenocarcinoma|
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|
|Estimated Enrollment :||3000 participants|
|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.|
|Study Start Date :||January 2006|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||January 2024|
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.
- 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 ]
- The secondary goal is to create a tissue and serum repository for future biomarker studies. [ Time Frame: 5 plus years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574327
|Contact: April D Higbee, RN, BSN||816-861-4700 ext firstname.lastname@example.org|
|Contact: Tracy B Shipe||816-861-4700 ext email@example.com|
|United States, Missouri|
|Department of Veterans Affairs Medical Center||Recruiting|
|Kansas City, Missouri, United States, 64128|
|Principal Investigator: Prateek Sharma, MD|
|Sub-Investigator: Sharad Mathur, MD|
|Sub-Investigator: Prashant Pandya, DO|
|Principal Investigator:||Prateek Sharma, MD||Department of Veterans Affairs Medical Center of Kansas City|