Inflammatory Mediators as Potential Non-Invasive Biomarkers in Subjects With Eosinophilic Esophagitis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 1 - 18 |
| Updated: | 2/2/2019 |
| Start Date: | February 2011 |
| End Date: | July 2019 |
Inflammatory Mediators as Potential Non-Invasive Biomarkers and Understanding the Mechanism of Remodeling in Tissue Biopsies in Subjects With Eosinophilic Esophagitis: A Pilot Study
The investigators seek to assess esophageal inflammation or lack of it in response to
treatment with a novel non-invasive method that would measure eosinophil-associated
inflammatory mediators in the blood and urine to determine the presence of active
Eosinophilic Esophagitis. For these purposes, the investigators will correlate esophageal
inflammatory mediators measured in blood and urine with histological findings identified on
esophageal mucosal biopsies. Additionally, biopsies associated mediators will be assessed
relative to clinical phenotype and outcome.
treatment with a novel non-invasive method that would measure eosinophil-associated
inflammatory mediators in the blood and urine to determine the presence of active
Eosinophilic Esophagitis. For these purposes, the investigators will correlate esophageal
inflammatory mediators measured in blood and urine with histological findings identified on
esophageal mucosal biopsies. Additionally, biopsies associated mediators will be assessed
relative to clinical phenotype and outcome.
The diagnosis, assessment of recurrence of inflammation, response to treatment and remission
in EoE are all currently based on histological evaluation of upper endoscopic pinch
esophageal biopsies. Obtaining biopsies for histological evaluation by this procedure is both
invasive and expensive. The purpose of our longitudinal prospective study is to evaluate and
quantify a panel of novel non-invasive eosinophilic inflammatory biomarkers in the blood and
urine of subjects with EoE and compare their presence and levels with the presence or absence
of measures of inflammation in esophageal biopsies. While evaluation of esophageal biopsies
with 15 or more eosinophils per high power field is the gold standard for diagnosis of EoE,
novel predictors of clinical outcome remain unclear. The objective is to identify one or more
sensitive and specific non-invasive biomarkers that could be used to monitor esophageal
inflammation, and identify novel tissue-based markers that identify phenotype and outcome.
This would eliminate the need for invasive serial surveillance endoscopies for the purpose of
evaluating for recurrence of inflammation or response to standard therapy since symptoms
alone do not adequately correlate with either the presence or absence of disease activity
(inflammation) in the esophagus of patients with EoE.
in EoE are all currently based on histological evaluation of upper endoscopic pinch
esophageal biopsies. Obtaining biopsies for histological evaluation by this procedure is both
invasive and expensive. The purpose of our longitudinal prospective study is to evaluate and
quantify a panel of novel non-invasive eosinophilic inflammatory biomarkers in the blood and
urine of subjects with EoE and compare their presence and levels with the presence or absence
of measures of inflammation in esophageal biopsies. While evaluation of esophageal biopsies
with 15 or more eosinophils per high power field is the gold standard for diagnosis of EoE,
novel predictors of clinical outcome remain unclear. The objective is to identify one or more
sensitive and specific non-invasive biomarkers that could be used to monitor esophageal
inflammation, and identify novel tissue-based markers that identify phenotype and outcome.
This would eliminate the need for invasive serial surveillance endoscopies for the purpose of
evaluating for recurrence of inflammation or response to standard therapy since symptoms
alone do not adequately correlate with either the presence or absence of disease activity
(inflammation) in the esophagus of patients with EoE.
Inclusion Criteria:
- Patient ages 1-18 undergoing upper endoscopy for suspected esophageal disease or
esophageal inflammation or has histologically confirmed esophageal inflammation may be
included in this study
Exclusion Criteria:
- Patients with a history or current diagnosis of esophageal malignancy or subjects with
graft versus host disease will be excluded from the study.
- Patients that are considered at high risk for biopsies at the discretion of the
child's physician and/or the researcher
- Patients with known bleeding disorders or patients with illnesses where bleeding would
pose a threat to their health
- Diagnosis other than Eosinophilic Esophagitis (EoE) i.e. IBD, GERD
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