Risk Factors and Biomarkers for Diagnosis and Treatment of EoE

NCT ID: NCT01988285

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2026-08-31

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.

Conditions

Eosinophilic Esophagitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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 have specimens collected and complete a questionnaire.

Specimen Collection

Intervention Type: OTHER

Blood collection, possible saliva collection, possible urine collection, and biopsy collection

Questionnaires

Intervention Type: OTHER

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

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 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.

Specimen Collection

Intervention Type: OTHER

Blood collection, possible saliva collection, possible urine collection, and biopsy collection

Questionnaires

Intervention Type: OTHER

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

Interventions

Specimen Collection

Blood collection, possible saliva collection, possible urine collection, and biopsy collection

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evan S Dellon, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

11-1122

Identifier Type: -

Identifier Source: org_study_id