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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK090073 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specimen Collection | Other | Blood collection, possible saliva collection, possible urine collection, and biopsy collection |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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The source of the study population will be patients aged 18 or older presenting at the gastrointestinal (Gl) Endoscopy Clinic at UNC-Chapel Hill for elective upper endoscopy with dysphagia and/or reflux symptoms.
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| Name | Affiliation | Role |
|---|---|---|
| Evan S Dellon, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina, Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 8, 2021 | Jun 23, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Esophageal, gastric, and duodenal biopsies, blood samples, saliva, urine.
| Questionnaires | 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 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |