Risk Factors and Biomarkers for Diagnosis and Treatment of EoE

Eosinophilic Esophagitis Clinical Trial

Official title:

Risk Factors and Biomarkers for Diagnosis and Treatment of EoE

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01988285
• Other study ID #: 11-1122
• Status: Active, not recruiting
• Start date: July 2011
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Other:
• Specimen Collection
Blood collection, possible saliva collection, possible urine collection, and biopsy collection
• Questionnaires
Subjects will complete a questionnaire utilizing validated symptom-specific instruments (Mayo Dysphagia Scale; GERD-HRQL Scale). The questionnaire will also record patient demographics, medical history, and current and past medication use

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum biomarker change following treatment in EoE cases	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.	Enrollment (Day 1) and approximately 8 weeks after initial EGD
Primary	Risk factors in EoE diagnosis	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.	Enrollment (day 1)
Secondary	Inflammatory serum biomarker measures	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.	Enrollment (day 1)