Clinical and Molecular Assessment of Men With High Risk for Esophageal Disorders
Completed
Conditions studied: Esophageal Diseases
In brief
In this study,the investigators will evaluate participants that have clinical features associated with an increased risk of esophageal disorders.The investigators will also see if there is a positive association of esophageal disorders in men,40-60 with or without abdominal obesity in the diagnosis of the following diseases; Gastroesophageal reflux disease, Barrett Esophagus and Esophageal Adenocarcinoma. The investigators hypothesize that most obese patients referred for Esophagogastroduodenoscopy will exhibit esophageal disorders. Since currently the rates of obesity and adenocarcinoma of the esophagus have increased significantly over the past 15 years, the investigators hope to find biochemical markers (i.e. pro-inflammatory mediators) in the esophagus. The investigators hope these samples will lead us to a differential expression of molecular markers and inflammatory mediators in the varying degrees of esophageal disorder
Key facts
- Study ID
- NCT02476513
- Run by
- University of Alabama at Birmingham
- People needed
- 18
- Starts
- 2014-02-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2018-03-08
Who can join
Age: 25 and older, up to 75. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Men only who are referred for upper endoscopy for the first time.Or who have had normal upper endoscopy in the last 10 years
- Age criteria: 25-75 years in age
- Patients undergoing EGD and willing to also consent to tissue biopsy, blood work and CT scan.
- ECOG PFS 0-1
You may not qualify if…
- Unstable medical condition, such as uncontrolled diabetes mellitus or hypertension or active infections requiring systemic therapy
- Clinical evidence of cardiac or pulmonary dysfunction including, but not limited to, unstable congestive heart failure, uncontrolled arrhythmias, unstable coagulation disorders, or recent myocardial infarction (within 6 months)
- Documented history of erosive esophagitis or non-erosive esophageal luminal. No prior history of Barrett's esophagus.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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