Esophageal String Test in Eosinophilic Esophagitis
Phase 2 Study of Esophageal String Test in Diagnosing Eosinophilic Esophagitis
2 other identifiers
observational
440
1 country
6
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2009
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 6, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedMarch 29, 2024
March 1, 2024
16 years
December 6, 2013
March 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Association of biomarker levels in biopsy tissue with pathological findings (eosinophil counts)
12 weeks
Secondary Outcomes (1)
Correlation for the level of each biomarker between EST and tissue biopsy samples
12 weeks
Other Outcomes (2)
Ability of an individual biomarker (or combination of biomarkers) to differentiate mucosal biopsy EBP sample obtained before and after treatment
12 weeks
Ability of an individual biomarker (or combination of biomarkers) to differentiate post-treatment mucosal biopsy EBP sample from normal control
12 weeks
Study Arms (3)
EoE active disease
Inflammation as defined by \>15 eos / HPF
EoE remission
No inflammation in EoE patients after treatment
normal control
No inflammation
Eligibility Criteria
Any pediatric or adult patient undergoing a clinically indicated endoscopy with biopsy at a participating site may be recruited. (initial cohort)
You may qualify if:
- 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:
- abdominal pain,
- vomiting,
- growth delay, or
- malabsorption for which an etiology has not been determined.
- Patients with chronic eosinophilic esophagitis (EoE) in whom symptoms suggest ongoing inflammation.
You may not qualify if:
- 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:
- esophageal stricture, or
- surgery such as fundoplication, or
- allergy to gelatin, or
- inability to swallow pills.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- University of Illinois at Chicagocollaborator
- Northwestern Universitycollaborator
- OSF Healthcare Systemcollaborator
Study Sites (6)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Northwestern University
Chicago, Illinois, 60601, United States
Lurie Children's Hospital
Chicago, Illinois, 60611, United States
OSF St Francis Medical Center
Peoria, Illinois, 61603, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Related Publications (2)
Furuta GT, Kagalwalla AF, Lee JJ, Alumkal P, Maybruck BT, Fillon S, Masterson JC, Ochkur S, Protheroe C, Moore W, Pan Z, Amsden K, Robinson Z, Capocelli K, Mukkada V, Atkins D, Fleischer D, Hosford L, Kwatia MA, Schroeder S, Kelly C, Lovell M, Melin-Aldana H, Ackerman SJ. The oesophageal string test: a novel, minimally invasive method measures mucosal inflammation in eosinophilic oesophagitis. Gut. 2013 Oct;62(10):1395-405. doi: 10.1136/gutjnl-2012-303171. Epub 2012 Aug 15.
PMID: 22895393BACKGROUNDAckerman SJ, Kagalwalla AF, Hirano I, Gonsalves N, Katcher PM, Gupta S, Wechsler JB, Grozdanovic M, Pan Z, Masterson JC, Du J, Fantus RJ, Alumkal P, Lee JJ, Ochkur S, Ahmed F, Capocelli K, Melin-Aldana H, Biette K, Dubner A, Amsden K, Keeley K, Sulkowski M, Zalewski A, Atkins D, Furuta GT. One-Hour Esophageal String Test: A Nonendoscopic Minimally Invasive Test That Accurately Detects Disease Activity in Eosinophilic Esophagitis. Am J Gastroenterol. 2019 Oct;114(10):1614-1625. doi: 10.14309/ajg.0000000000000371.
PMID: 31567192BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Glenn T Furuta, MD
Children's Hospital Colorado
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2013
First Posted
December 11, 2013
Study Start
January 1, 2009
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
March 29, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share