Risk Factors and Biomarkers for Diagnosis and Treatment of EoE

Active, not recruiting

• Conditions: Eosinophilic Esophagitis
• Interventions: Other: Specimen Collection; Other: Questionnaires

• Registration Number: NCT01988285
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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: Up to a total of 800 participants (approximately 400 with EoE and 400 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. 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, possible saliva collection, possible urine 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, including eotaxin-3 and IL-13.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 800

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 or older

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dysphagia and GERD controls	Questionnaires	The cross-sectional arm will consist of patients who are having a clinically indicated endoscopy for reflux and/or dysphagia. Cross-sectional participants will have specimens collected and complete a questionnaire.
Prospective Longitudinal EoE Cases	Specimen Collection	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 have specimens collected and complete questionnaires s prior to their standard of care clinical therapy of swallowed steroids and at their clinically indicated follow up upper endoscopy.
Prospective Longitudinal EoE Cases	Questionnaires	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 have specimens collected and complete questionnaires s prior to their standard of care clinical therapy of swallowed steroids and at their clinically indicated follow up upper endoscopy.
Dysphagia and GERD controls	Specimen Collection	The cross-sectional arm will consist of patients who are having a clinically indicated endoscopy for reflux and/or dysphagia. Cross-sectional participants will have specimens collected and complete a questionnaire.

Primary Outcome Measures

Name	Time	Method
Risk factors in EoE diagnosis	Enrollment (day 1)	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

Name	Time	Method
Inflammatory serum biomarker measures	Enrollment (day 1)	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.

Trial Locations

Locations (1)

University of North Carolina, Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States