Inflammatory Mediators as Potential Non-Invasive Biomarkers in Subjects

Status Active, not recruiting

Clinical Trial Summary

The investigators seek to assess esophageal inflammation or lack of it in response to treatment with a novel non-invasive method that would measure eosinophil-associated inflammatory mediators in the blood and urine to determine the presence of active Eosinophilic Esophagitis. For these purposes, the investigators will correlate esophageal inflammatory mediators measured in blood and urine with histological findings identified on esophageal mucosal biopsies. Additionally, biopsies associated mediators will be assessed relative to clinical phenotype and outcome.

Clinical Trial Description

The diagnosis, assessment of recurrence of inflammation, response to treatment and remission in EoE are all currently based on histological evaluation of upper endoscopic pinch esophageal biopsies. Obtaining biopsies for histological evaluation by this procedure is both invasive and expensive. The purpose of our longitudinal prospective study is to evaluate and quantify a panel of novel non-invasive eosinophilic inflammatory biomarkers in the blood and urine of subjects with EoE and compare their presence and levels with the presence or absence of measures of inflammation in esophageal biopsies. While evaluation of esophageal biopsies with 15 or more eosinophils per high power field is the gold standard for diagnosis of EoE, novel predictors of clinical outcome remain unclear. The objective is to identify one or more sensitive and specific non-invasive biomarkers that could be used to monitor esophageal inflammation, and identify novel tissue-based markers that identify phenotype and outcome. This would eliminate the need for invasive serial surveillance endoscopies for the purpose of evaluating for recurrence of inflammation or response to standard therapy since symptoms alone do not adequately correlate with either the presence or absence of disease activity (inflammation) in the esophagus of patients with EoE. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03822325
Study type	Observational [Patient Registry]
Source	Ann & Robert H Lurie Children's Hospital of Chicago
Contact
Status	Active, not recruiting
Phase
Start date	February 2011
Completion date	May 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03382678` - CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry
Completed	`NCT05083312` - Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial	Phase 3
Completed	`NCT04593251` - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis	Phase 1
Completed	`NCT03633617` - Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)	Phase 3
Terminated	`NCT04543409` - A Study of Benralizumab in Patients With Eosinophilic Esophagitis	Phase 3
Completed	`NCT04941742` - The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)
Terminated	`NCT02314455` - Esophageal Absorption in EoE	N/A
Completed	`NCT01953575` - Mucosal Impedance and Eosinophilic Esophagitis	N/A
Completed	`NCT01386112` - Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis	Phase 1/Phase 2
Recruiting	`NCT04991935` - Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis	Phase 3
Not yet recruiting	`NCT05896891` - San Raffaele EoE Biobank
Active, not recruiting	`NCT05482256` - A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis	N/A
Recruiting	`NCT04149470` - Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)	Phase 4
Recruiting	`NCT04416217` - Eosinophilic Esophagitis Steroid Safety Study
Completed	`NCT05084963` - A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis	Phase 2
Completed	`NCT02579876` - Milk Patch for Eosinophilic Esophagitis	Phase 2
Recruiting	`NCT02331849` - Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry.	N/A
Active, not recruiting	`NCT02202590` - Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus	N/A
Active, not recruiting	`NCT05176249` - Prospective Database for Eosinophilic Esophagitis (EoE) of Pediatric Population
Completed	`NCT00961233` - Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Inflammatory Mediators as Potential Non-Invasive Biomarkers in Subjects With Eosinophilic Esophagitis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms