Esophageal DiseasesNCT02476513
Clinical and Molecular Assessment of Men With High Risk for Esophageal Disorders
An observational study of Esophageal Diseases, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 75 years, men only
- Conditions the study is for
- Esophageal Diseases
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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
Read the detailed description
Patients with elevated central adiposity have an increased risk of esophageal disorders; we will correlate central adiposity with advanced esophageal pathologies (BE and EAC). This will be done by comparing body mass and fat distribution to tissue abnormalities found by pathology review of EGD biopsy. It is anticipated that the group of men in this study will have an increased likelihood of histopathologic alteration, which we will fit into our scale (0-no inflammation, 1-inflammation or BE, 2-BE with dysplasia, and 3-carcinoma) according to the referral pattern at UAB's outpatient gastroenterology clinic.
At the molecular level, there is also a relationship between pro-inflammatory cytokines and obesity, which may contribute to esophageal disorder [28]. Metabolically active fat cells secrete cytokines exclusive to adipose tissue (adipokines, leptin/adiponectin) as well as the more classic signaling molecules, tumor necrosis factor alpha (TNF-α); interleukins (IL)-1, IL-6, IL-8, and IL-10; monocyte chemoattractant protein 1 (MCP-1); and macrophage inflammatory protein 1 (MIP 1) [29-33]. Obesity-triggered pro-inflammatory molecules may promote tissue injury, leading to metaplasia and dysplasia in BE and, subsequently, to carcinoma.
Thus, by measuring these pro-inflammatory markers in our prospective patient population, it will be determined if patients with elevated levels exhibit pathologic disorders in the esophagus and if the differential expression of these molecular markers correlates with degree of esophageal disorder. We will analyze samples collected from men for adipocytokines and for inflammatory mediators that are released with tissue injury. Additionally, we will examine molecular markers that correlate with more advanced esophageal disorders (BE with high grade dysplasia and EAC).
Persistent stimulation is needed to cause stepwise progression from the early stages of esophageal injury, to BE, to carcinoma. Since the molecular events that lead to this transformation are not known, our goal is to profile biopsy tissues collected from the prospective cohort of 60 men, analyzed by IHC for p53, Ki67, cyclin D1, IL-6, IL-8, Cox-2, DKK-1, CD44, leptin, and adiponectin. These molecules are known to be involved in transformation of normal esophageal epithelium to EACs via progression from metaplasia and BE to low-grade dysplasia and high-grade dysplasia. [34]. The clinical outcome measurements will be correlated with the levels of these molecules, determined by IHC, with metaplasia, degree of dysplasia in BE, and stage of EAC. For BE tissues, there is a correlation between the extent of p53 staining and aggressive clinical features. Our preliminary findings on six BEs, selected from the patient population at UAB, indicate that a high proportion of p53 staining directly correlates with high-grade lesions
- Conditions
- Esophageal Diseases
- Medical subject headings
- Esophageal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2 years
Secondary outcomes (1)
Developing a group of tissue markers that specifically relates to a increase in esophageal cancer
The pathologist and bio-marker laboratory will use the blood samples and tissue to provide a assay that can be used later to provide insight into the increase risk of developing Barrett's esophagus or esophageal adenocarcinoma
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startFeb 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal DiseasesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James A Posey, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476513
- Sponsor's protocol ID
- UAB 1354
- Status last verified
- Mar 2018
- First submitted
- 27 Oct 2014
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Molecular Assessment of Men With High Risk for Esophageal Disorders
- ClinicalTrials.gov ID
- NCT02476513
- Acronym / sponsor ID
- UAB 1354
- Conditions
- Esophageal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Patients with elevated central adiposity have an increased risk of esophageal disorders; we will correlate central adiposity with advanced esophageal pathologies (BE and EAC). This will be done by comparing body mass and fat distribution to tissue abnormalities found by pathology review of EGD biopsy. It is anticipated that the group of men in this study will have an increased likelihood of histopathologic alteration, which we will fit into our scale (0-no inflammation, 1-inflammation or BE, 2-BE with dysplasia, and 3-carcinoma) according to the referral pattern at UAB's outpatient gastroenterology clinic.
At the molecular level, there is also a relationship between pro-inflammatory cytokines and obesity, which may contribute to esophageal disorder [28]. Metabolically active fat cells secrete cytokines exclusive to adipose tissue (adipokines, leptin/adiponectin) as well as the more classic signaling molecules, tumor necrosis factor alpha (TNF-α); interleukins (IL)-1, IL-6, IL-8, and IL-10; monocyte chemoattractant protein 1 (MCP-1); and macrophage inflammatory protein 1 (MIP 1) [29-33]. Obesity-triggered pro-inflammatory molecules may promote tissue injury, leading to metaplasia and dysplasia in BE and, subsequently, to carcinoma.
Thus, by measuring these pro-inflammatory markers in our prospective patient population, it will be determined if patients with elevated levels exhibit pathologic disorders in the esophagus and if the differential expression of these molecular markers correlates with degree of esophageal disorder. We will analyze samples collected from men for adipocytokines and for inflammatory mediators that are released with tissue injury. Additionally, we will examine molecular markers that correlate with more advanced esophageal disorders (BE with high grade dysplasia and EAC).
Persistent stimulation is needed to cause stepwise progression from the early stages of esophageal injury, to BE, to carcinoma. Since the molecular events that lead to this transformation are not known, our goal is to profile biopsy tissues collected from the prospective cohort of 60 men, analyzed by IHC for p53, Ki67, cyclin D1, IL-6, IL-8, Cox-2, DKK-1, CD44, leptin, and adiponectin. These molecules are known to be involved in transformation of normal esophageal epithelium to EACs via progression from metaplasia and BE to low-grade dysplasia and high-grade dysplasia. [34]. The clinical outcome measurements will be correlated with the levels of these molecules, determined by IHC, with metaplasia, degree of dysplasia in BE, and stage of EAC. For BE tissues, there is a correlation between the extent of p53 staining and aggressive clinical features. Our preliminary findings on six BEs, selected from the patient population at UAB, indicate that a high proportion of p53 staining directly correlates with high-grade lesions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of obesity and increase risk of esophageal adenocarcinomas
Time frame: 1-2 years
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 secondary outcome
Developing a group of tissue markers that specifically relates to a increase in esophageal cancer
Time frame: 1-2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A Posey, M.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Diseases, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of obesity and increase risk of esophageal adenocarcinomas (time frame: 1-2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.