Clinical and Molecular Assessment of Men With High Risk for Esophageal Disorders

NCT02476513 | Completed DMC

• 1 other identifier: UAB 1354
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Diseases

Outcome Measures

Primary Outcomes (1)

• Correlation of obesity and increase risk of esophageal adenocarcinomas

  We will use data collected from the waist measurements and the measurement compiled from the CT scan of the abdomen. The correlate it with the actual tissue markers(if any) found from the pathologists review.

  1-2 years

Secondary Outcomes (1)

• Developing a group of tissue markers that specifically relates to a increase in esophageal cancer

  1-2 years

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The goal of the study is to further clarify the relationship among esophageal disorders, obesity and inflammatory mediators that may identify a high risk patient profile that would warrant more frequent screening. We will accrue 60 men between the ages of 25 and 75 who are referred for upper endoscopy for the first time or subject who have had a normal upper endoscopy in the last 10 years. It is anticipated that some of the participants will not have symptoms of reflux or dyspepsia. Due to the pattern of referral, however, most will exhibit risk factors of esophageal disorders.

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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The H\&E sections of all biopsy specimens will be reviewed by a GI diagnostic pathologist, Leona Council, MD, for histopathologic parameters including histologic grade and type. The histology will be characterized according to the scale depicted in figure 1, where 0 represents the earliest possible injury and 3 represents malignancy. All specimens will be processed in the typical manner, but reviewed by Dr. Council in the pathology department.

MeSH Terms

Conditions

Esophageal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• James A Posey, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: June 19, 2015
• Study Start: February 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 8, 2018

Record last verified: 2018-03

Locations

US (1)