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Esophageal String Test in Eosinophilic Esophagitis

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by University of Colorado, Denver
Sponsor:
Collaborators:
University of Illinois at Chicago
Northwestern University
OSF St. Francis Medical Center
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02008903
First received: December 6, 2013
Last updated: April 26, 2017
Last verified: April 2017
  Purpose

The overall goal of this study is to develop a novel minimally invasive device, the Esophageal String Test (EST) to monitor esophageal inflammation during treatment of the rare disease Eosinophilic Esophagitis (EoE) in a safe and efficacious manner.

This study is broken down into 2 specific aims:

Specific Aim 1: Identify the EoE Biomarker Panel (EBP) that will improve the sensitivity and specificity of the EST for documenting esophageal inflammation in a 1-hour time point.

Specific Aim 2: Validate the ability of the EST EBP to monitor therapeutic efficacy in a 1-hour sampling time.

Funding Source - FDA OOPD


Condition
Eosinophilic Esophagitis

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Phase 2 Study of Esophageal String Test in Diagnosing Eosinophilic Esophagitis

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Association of biomarker levels in biopsy tissue with pathological findings (eosinophil counts) [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Correlation for the level of each biomarker between EST and tissue biopsy samples [ Time Frame: 12 weeks ]

Other Outcome Measures:
  • Ability of an individual biomarker (or combination of biomarkers) to differentiate mucosal biopsy EBP sample obtained before and after treatment [ Time Frame: 12 weeks ]
  • Ability of an individual biomarker (or combination of biomarkers) to differentiate post-treatment mucosal biopsy EBP sample from normal control [ Time Frame: 12 weeks ]

Estimated Enrollment: 440
Study Start Date: January 2009
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
EoE active disease
Inflammation as defined by >15 eos / HPF
EoE remission
No inflammation in EoE patients after treatment
normal control
No inflammation

Detailed Description:

Eosinophilic esophagitis (EoE) is an increasingly recognized rare disease of children and adults characterized by symptoms including nausea, vomiting, abdominal pain, dysphagia and food impaction that occur in conjunction with esophageal eosinophilia. To date, the only method to make EoE diagnoses and follow treatment responses in EoE is invasive endoscopy with biopsy. While endoscopy is generally safe, an accurate, less invasive, inexpensive, comprehensive and durable test is urgently needed to determine therapeutic efficacy. To address this need, the investigators will use a novel application of an existing technology, the Enterotest™ (a string-based test used to detect intestinal Giardiasis), to measure esophageal inflammation (herein termed the Esophageal String Test - EST). The investigators supportive Preliminary Data provide proof-of-principle for the ability of ESTs to capture esophageal inflammatory mediators in luminal samples from patients affected with EoE. The investigators prospective study demonstrates that: (1) levels of eosinophil-derived granule proteins (MBP1, EDN, ECP, EPX, CLC/Gal-10) in esophageal mucosal biopsies correlate with levels quantitated in EST-captured samples, i.e., levels in luminal secretions captured by the EST correlate with mucosal inflammation, and (2) these luminal biomarkers of eosinophilic inflammation significantly correlate with EoE disease activity. These findings provide strong support for using ESTs as novel minimally invasive instruments to monitor therapeutic efficacy in EoE. The global objective of this project is therefore to bring the "Esophageal String Test" (EST) to commercialization, so that it can be used to monitor therapeutic efficacy in children and adults with EoE. The investigators hypothesize that ESTs will capture an EoE Biomarker Panel (EBP) reflective of disease activity. The Specific Aims are to: (1) Identify an EoE Biomarker Panel (EBP) that will improve the sensitivity and specificity of the EST for monitoring disease activity and (2) Validate the ability of the EST EBP to monitor therapeutic efficacy in 1-hour sampling time. The investigators supportive Preliminary Data demonstrate the feasibility of using ESTs in both children and adults with EoE to measure disease activity (esophageal inflammation) in an overnight (12-hour) test, and shorter time periods, currently performed before a scheduled endoscopy with biopsy. In this project, The investigators propose to shorten this time frame to a 1-hour test, a clinically relevant time point that will markedly facilitate its use and potential impact in the outpatient clinic setting.

Public Health Relevance/Impacts: At least four major impacts should result from these studies:

(1) Identification of an EBP will permit monitoring of esophageal inflammation in EoE; (2) the EBP will be relevant to following disease progression, treatment responses, management and pathogenesis of EoE, (3) validation of the EST EBP will enable development of rapid and inexpensive assays to follow treatment responses, thus reducing the number of follow-up endoscopies with biopsy that are currently performed, and (4) provide a device to monitor EoE disease activity where endoscopy with biopsy may not be available or affordable.

  Eligibility

Ages Eligible for Study:   7 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any pediatric or adult patient undergoing a clinically indicated endoscopy with biopsy at a participating site may be recruited. (initial cohort)
Criteria

Inclusion Criteria:

  • Patients undergoing esophagogastroduodenoscopy (EGD) at Children's Hospital Colorado, or
  • Patients from a participating site in whom an inflammatory GI disease is suspected.
  • Patients with symptoms of:

    1. abdominal pain,
    2. vomiting,
    3. growth delay, or
    4. malabsorption for which an etiology has not been determined.
  • Patients with chronic eosinophilic esophagitis (EoE) in whom symptoms suggest ongoing inflammation.

Exclusion Criteria:

  • Patients suffering from bleeding diathesis, or any other comorbid condition which their doctor feels may put them at additional risk.
  • Patients with a family history of connective tissue disease.
  • Patients undergoing a therapeutic endoscopy (such as dilatation, sclerotherapy, variceal banding).
  • Patients with a history of:

    1. esophageal stricture, or
    2. surgery such as fundoplication, or
    3. allergy to gelatin, or
    4. inability to swallow pills.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02008903

Contacts
Contact: Susanna Kantor 720-777-4800 susanna.kantor@childrenscolorado.org
Contact: Faria Ahmed 720-777-2797 faria.ahmed@childrenscolorado.org

Locations
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Faria Ahmed    720-777-2797    faria.ahmed@childrenscolorado.org   
Contact: Glenn T Furuta, MD    720-777-7457    glenn.furuta@childrenscolorado.org   
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Allison Dubner    303-724-8974    Allison.Dubner@ucdenver.edu   
Principal Investigator: Paul Menard-Katcher, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60601
Contact: Angelika Zalewski    312-695-4054    angelika.zalewski@northwestern.edu   
Contact: Ikuo Hirano, MD       i-hirano@northwestern.edu   
Principal Investigator: Ikuo Hirano, MD         
Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Jessica Ross    312-227-4582    jnross@luriechildrens.org   
Contact: Amir F Kagalwalla, MBBS       akagalwalla@luriechildrens.org   
Principal Investigator: Amir F Kagalwalla, MBBS         
OSF St Francis Medical Center Recruiting
Peoria, Illinois, United States, 61603
Contact: Jocelyn T Perry, RN    309-624-4087    Jocelyn.K.Perry@osfhealthcare.org   
Contact: Sandeep Gupta, MD       skgupta@uicomp.uic.edu   
Principal Investigator: Sandeep Gupta, MD         
United States, Indiana
Indiana University Completed
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
University of Colorado, Denver
University of Illinois at Chicago
Northwestern University
OSF St. Francis Medical Center
Investigators
Principal Investigator: Glenn T Furuta, MD Children's Hospital Colorado
  More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02008903     History of Changes
Other Study ID Numbers: 07-0223
FD-R-G04086-01 ( Other Identifier: FDA )
Study First Received: December 6, 2013
Last Updated: April 26, 2017

Additional relevant MeSH terms:
Eosinophilic Esophagitis
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 26, 2017