View Clinical Trial (Medical Research Study)
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.
| City: |
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Kansas City |
| State: |
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Missouri |
| Zip Code: |
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64128 |
| Conditions: |
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Barrett's Esophagus - Gastroesophageal Reflux Disease - Esophageal Adenocarcinoma |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00574327 |
| Primary Contact: |
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Principal Investigator
Prateek Sharma, MD
Department of Veterans Affairs Medical Center of Kansas City
April D Higbee, RN, BSN
Phone: 816-861-4700 ext. 57456
Email: april.higbee@va.gov
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| Backup Contact: |
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Email: tracy.shipe@va.gov
Tracy B Shipe
Phone: 816-861-4700 ext. 57994
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| Location Contact: |
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Kansas City, Missouri 64128
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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