Risk Factors and Biomarkers for Diagnosis and Treatment of EoE
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Risk Factors and Biomarkers for Diagnosis and Treatment of EoE|
- 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.
- 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.
- 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.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01988285
|United States, North Carolina|
|University of North Carolina, Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Evan S Dellon, MD, MPH||University of North Carolina, Chapel Hill|