NCT02453126

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

9.5 years

First QC Date

September 16, 2014

Last Update Submit

February 2, 2024

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic EsophagitisEsophageal Stricture

Outcome Measures

Primary Outcomes (1)

  • Stricture, as measured by endoscopic assessment

    Day 1

Secondary Outcomes (1)

  • Decreased esophageal distensibility, as determined by EndoFlip

    Day 1

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Scheduled to undergo a clinical upper endoscopy with biopsy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Eosinophilic EsophagitisEsophageal Stenosis

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Calies Menard-Katcher, MD

    University of Colorado/Childrens Hospital Colorado

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassandra Burger

CONTACT

720-777-5739cassandra.burger@childrenscolorado.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

May 25, 2015

Study Start

December 1, 2014

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

February 5, 2024

Record last verified: 2024-02

Locations

US(1)