Risk Factors and Biomarkers for Diagnosis and Treatment of EoE

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01988285
First received: October 25, 2013
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

Purpose: To validate our previously developed model of risk factors for diagnosis of eosinophilic esophagitis (EoE), and to assess the utility of serum levels of biomarkers in diagnosis and monitoring of treatment of EoE. Participants: A total of 180 adult outpatients (60 with EoE and 120 without EoE) who are referred for upper endoscopy. Procedures: This is a prospective cohort study.

Patients will be compared with newly diagnosed EoE to non-EoE controls, obtain baseline measures, reassess EoE patients after treatment, and also reassess untreated controls. Data collection will include questionnaire results, blood collection, and tissue collection (esophageal biopsies performed during upper endoscopy per pre-specified protocol). Blood will be analyzed for the presence of the candidate biomarkers.


Condition
Eosinophilic Esophagitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors and Biomarkers for Diagnosis and Treatment of EoE

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Risk factors in EoE diagnosis [ Time Frame: Enrollment (day 1) ] [ Designated as safety issue: No ]
    To validate our model of clinical, endoscopic, and histopathologic risk factors for diagnosis of EoE by calculating the EoE risk score which includes subject's age, allergic conditions, endoscopic findings, and eosinophil count. Subject's EoE risk scores will be compared between EoE patients and two non-EoE control groups: patients with dysphagia and patients with gastroesophageal reflux disease (GERD) who are not responsive to proton pump inhibitor (PPI) therapy.


Secondary Outcome Measures:
  • Inflammatory serum biomarker measures [ Time Frame: Enrollment (day 1) ] [ Designated as safety issue: No ]
    To assess operating characteristics of serum biomarkers eotaxin-3 and IL-13 for diagnosis of incident cases of EoE as compared with two non-EoE control groups: patients with dysphagia and patients with GERD who are not responsive to PPI therapy.


Other Outcome Measures:
  • Serum biomarker change following treatment in EoE cases [ Time Frame: Enrollment (Day 1) and approximately 8 weeks after initial EGD ] [ Designated as safety issue: No ]
    To determine the effect of clinically indicated topical steroid therapy on non-invasive serum biomarkers eotaxin-3 and IL-13 for monitoring treatment response in incident EoE cases.


Biospecimen Retention:   Samples With DNA

Esophageal, gastric, and duodenal biopsies. Blood samples.


Estimated Enrollment: 180
Study Start Date: July 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dysphagia and GERD controls

The cross-sectional arm will consist of patients who are having a clinically indicated endoscopy for reflux and/or dysphagia.

Cross-sectional participants will receive one-time study biopsies during a routine clinically indicated endoscopy.

Prospective Longitudinal EoE Cases

The prospective longitudinal group will be subjects who have a positive EoE diagnosis during initial endoscopy. This prospective group will be followed up at their clinically indicated endoscopy after their standard of care clinical therapy of swallowed steroids.

Prospective longitudinal participants will receive biopsies prior to their standard of care clinical therapy of swallowed steroids and at their clinically indicated follow up upper endoscopy.


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The source of the study population will be patients aged 18-80 presenting at the gastrointestinal (Gl) Endoscopy Clinic at UNC-Chapel Hill for elective upper endoscopy with a primary or secondary indication of dysphagia and/or reflux symptoms. Any patient undergoing endoscopy with dysphagia and/or reflux symptoms is eligible to participate in the study.

Criteria

Inclusion Criteria:

  1. Referral for upper endoscopy (esophagogastroduodenoscopy; EGD) to evaluate specific symptoms (dysphagia, heartburn, reflux, chest pain, regurgitation, abdominal pain, nausea, or vomiting).
  2. Age 18-80.

Exclusion Criteria:

  1. Acute GI bleeding.
  2. Known cancer of the esophagus, stomach, or small bowel.
  3. Prior esophageal resection.
  4. Esophageal varices.
  5. Active anticoagulation or bleeding diathesis.
  6. Medical instability (determined by the performing endoscopist) to precludes performing EGD.
  7. Pregnancy
  8. Inability to read or understand the consent form and questionnaire.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988285

Contacts
Contact: Jessica H Gebhart, MSHS 919-966-4591 jhores@med.unc.edu

Locations
United States, North Carolina
University of North Carolina, Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Jessica H Gebhart, MSHS    919-966-4591    jhores@med.unc.edu   
Contact: Susan Moist, MPH    919-966-7655    susan_moist@med.unc.edu   
Principal Investigator: Evan S Dellon, MD, MPH         
Sub-Investigator: Nicholas Shaheen, MD, MPH         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Evan S Dellon, MD, MPH University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01988285     History of Changes
Other Study ID Numbers: 11-1122
Study First Received: October 25, 2013
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

Additional relevant MeSH terms:
Esophageal Diseases
Esophagitis
Eosinophilic Esophagitis
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014