Inflammatory Mediators as Potential Non-Invasive Biomarkers in Subjects With Eosinophilic Esophagitis

August 31, 2023 updated by: Joshua Wechsler, Ann & Robert H Lurie Children's Hospital of Chicago

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago (UIC)
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H Lurie Childjren's Hospital of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Any patient undergoing a clinically indicated upper endoscopy with biopsy for suspected esophageal inflammation or esophageal disease, or who has histologically confirmed esophageal inflammation may be asked to enroll in this study. The investigators plan to recruit subjects for two years, and enroll up to 150 patients. The patients with a confirmed diagnosis of EoE will be followed in the study for two years after enrollment.

Description

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. Inflammatory Bowel Disease (IBD), Gastroesophageal Reflux Disease (GERD)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlate RNA and protein measures from esophageal biopsies with histologic, endoscopic and clinical aspects of disease along with non-invasive biomarkers
Time Frame: 5 years
Frozen biopsies and archived slides from EoE patients and controls will be used in testing molecules released by or expressed on the cell surface of inflammatory cells. The molecules will be assessed using RNA sequencing, ELISA, and immunohistochemistry. This information will be correlated with eosinophil counts along with endoscopy findings, treatment outcomes and clinical measures of the disease such as symptoms, atopic co-morbidities, and demographics.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

  • Principal Investigator: Joshua Wechsler, MD, Ann & Robert H Lurie Children's Hospital of Chicago
  • Principal Investigator: Barry Wershil, MD, Ann & Robert H. Lurie Children's Hospital fo Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2011

Primary Completion (Actual)

May 1, 2015

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

August 16, 2018

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-14155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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