Eosinophilic EsophagitisNCT02453126
Fibrostenotic Eosinophilic Esophagitis: Assessment Tools
An observational study of Eosinophilic Esophagitis, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Eosinophilic Esophagitis
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children, ages 5 to 18 years, scheduled to undergo a clinical upper endoscopy with biopsy for suspected or confirmed Eosinophilic Esophagitis.
Who may be able to join
- Scheduled to undergo a clinical upper endoscopy with biopsy
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Cassandra Burger, 720-777-5739, cassandra.burger@childrenscolorado.org
About this study
Official title: Fibrostenotic Eosinophilic Esophagitis: Endoscopic, Histologic and Molecular Characterization and Evaluation of Clinical Assessment Tools
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.
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophilic Esophagitis, Esophageal Stricture
- Medical subject headings
- Eosinophilic Esophagitis, Esophageal Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Stricture, as measured by endoscopic assessment
Measured: Day 1
Secondary outcomes (1)
Decreased esophageal distensibility, as determined by EndoFlip
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startDec 2014
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Calies Menard-Katcher, MD, Principal investigator, University of Colorado/Childrens Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453126
- Sponsor's protocol ID
- 14-0594
- Other IDs
- UL1TR001082
- Status last verified
- Feb 2024
- First submitted
- 16 Sep 2014
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrostenotic Eosinophilic Esophagitis: Endoscopic, Histologic and Molecular Characterization and Evaluation of Clinical Assessment Tools
- ClinicalTrials.gov ID
- NCT02453126
- Acronym / sponsor ID
- 14-0594
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophilic Esophagitis, Esophageal Stricture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 25 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children, ages 5 to 18 years, scheduled to undergo a clinical upper endoscopy with biopsy for suspected or confirmed Eosinophilic Esophagitis.
Key inclusion criteria (1 listed)
- Scheduled to undergo a clinical upper endoscopy with biopsy
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stricture, as measured by endoscopic assessment
Time frame: Day 1
1 secondary outcome
Decreased esophageal distensibility, as determined by EndoFlip
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
Related trials for Eosinophilic Esophagitis
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Patient-Centered Decision Support for Eosinophilic Esophagitis
Eosinophilic Esophagitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Calies Menard-Katcher, MD principal investigator
University of Colorado/Childrens Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cassandra Burger (720-777-5739, cassandra.burger@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stricture, as measured by endoscopic assessment (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.