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Fibrostenotic Eosinophilic Esophagitis: Assessment Tools

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ClinicalTrials.gov Identifier: NCT02453126
Recruitment Status : Recruiting
First Posted : May 25, 2015
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date September 16, 2014
First Posted Date May 25, 2015
Last Update Posted Date January 18, 2020
Study Start Date December 2014
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2015)
Stricture, as measured by endoscopic assessment [ Time Frame: Day 1 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 20, 2015)
Decreased esophageal distensibility, as determined by EndoFlip [ Time Frame: Day 1 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fibrostenotic Eosinophilic Esophagitis: Assessment Tools
Official Title Fibrostenotic Eosinophilic Esophagitis: Endoscopic, Histologic and Molecular Characterization and Evaluation of Clinical Assessment Tools
Brief Summary This protocol addresses a central hypothesis that fibrostenotic Eosinophilic Esophagitis (EoE) is characterized by abnormal esophageal structure and compliance compared to non fibrostenotic EoE and that distinctive cellular and molecular profiles predict the fibrostenotic phenotype. This study aims to define and assess the changes that occur in the structure and dynamics of the esophageal wall in pediatric Eosinophilic Esophagitis along with characterizing the histologic and molecular patterns in fibrostenotic EoE.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children, ages 5 to 18 years, scheduled to undergo a clinical upper endoscopy with biopsy for suspected or confirmed Eosinophilic Esophagitis.
Condition Eosinophilic Esophagitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 16, 2016)
150
Original Estimated Enrollment
 (submitted: May 20, 2015)
100
Estimated Study Completion Date June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Scheduled to undergo a clinical upper endoscopy with biopsy

Exclusion Criteria:

  • Known connective tissue disorder
  • Increased risk of bleeding
  • Inflammatory bowel disease, celiac disease, eosinophilic gastroenteritis, or any autoimmune disease
  • Other esophageal disease including known achalasia; history of caustic ingestion, esophageal surgery esophageal stricture for other known reason or other esophageal injury.
  • Use of oral or intravenous steroids in the preceding 60 days. (Swallowed topical fluticasone, budesonide, etc not included as exclusion criteria.)
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Faria Ahmed 720-777-2797 faria.ahmed@childrenscolorado.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02453126
Other Study ID Numbers 14-0594
UL1TR001082 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Not Provided
Investigators
Principal Investigator: Calies Menard-Katcher, MD University of Colorado/Childrens Hospital Colorado
PRS Account University of Colorado, Denver
Verification Date January 2020