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NCT01988285 · ClinicalTrials.gov registry record
Risk Factors and Biomarkers for Diagnosis and Treatment of EoE
A clinical trial of Eosinophilic Esophagitis, sponsored by University of North Carolina, Chapel Hill.
- Active
- Registry status
- 800
- Enrollment target
- 1
- Study location
NCT01988285: Active study of Eosinophilic Esophagitis, sponsored by University of North Carolina, Chapel Hill.
NCT01988285 is a study of Eosinophilic Esophagitis that is active but no longer recruiting, run by University of North Carolina, Chapel Hill. The registered enrollment target is 800 participants, roughly in line with the 846-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01988285, a study of Eosinophilic Esophagitis, is active but no longer recruiting, sponsored by University of North Carolina, Chapel Hill.
- ACTIVE NOT RECRUITING
- Registry status
- 800 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Questionnaires
- OTHER Specimen Collection
Study Locations (1)
North Carolina
- University of North Carolina, Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2011-07 |
| Est. Completion | 2026-08 |
What the registry record for NCT01988285 still lists
NCT01988285 is an observational study that tracks outcomes without assigning an intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 846-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target.
The record links to 1 condition, with Eosinophilic Esophagitis appearing as the primary indexed condition, and to 2 interventions - of which Questionnaires is the first listed.
NCT01988285 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01988285 about?
NCT01988285 is a clinical study titled "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: Up to a total of 800 participants (approximately 400 with EoE an...
What is the current status of trial NCT01988285?
This trial is currently active not recruiting. The enrollment target is 800 participants. The study started on 2011-07. Estimated completion is 2026-08.
What conditions does trial NCT01988285 study?
This clinical trial studies the following conditions: Eosinophilic Esophagitis.
What interventions are being tested in trial NCT01988285?
The interventions under investigation include: Questionnaires (OTHER), Specimen Collection (OTHER).
Who is sponsoring clinical trial NCT01988285?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01988285 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01988285's enrollment target sits among peer trials
800 6th of 44 higher than 39 of 44 other Eosinophilic Esophagitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Eosinophilic Esophagitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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