Risk Factors and Biomarkers for Diagnosis and Treatment of EoE
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/23/2018 |
| Start Date: | July 2011 |
| End Date: | August 2020 |
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.
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.
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.
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