Inflammatory Mediators as Potential Non-Invasive Biomarkers in Subjects With Eosinophilic Esophagitis
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| ClinicalTrials.gov Identifier: NCT03822325 |
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Recruitment Status :
Active, not recruiting
First Posted : January 30, 2019
Last Update Posted : February 7, 2022
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Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Joshua Wechsler, Ann & Robert H Lurie Children's Hospital of Chicago
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Brief 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.
| Condition or disease |
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| Eosinophilic Esophagitis |
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 Type : | Observational [Patient Registry] |
| Actual Enrollment : | 88 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | Inflammatory Mediators as Potential Non-Invasive Biomarkers and Understanding the Mechanism of Remodeling in Tissue Biopsies in Subjects With Eosinophilic Esophagitis: A Pilot Study |
| Actual Study Start Date : | February 2011 |
| Actual Primary Completion Date : | May 2015 |
| Estimated Study Completion Date : | May 2025 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Correlate RNA and protein measures from esophageal biopsies with histologic, endoscopic and clinical aspects of disease along with non-invasive biomarkers [ Time Frame: 5 years ]Frozen biopsies and archived slides from EoE patients and controls will be used in testing molecules released by or expressed on the cell surface of inflammatory cells. The molecules will be assessed using RNA sequencing, ELISA, and immunohistochemistry. This information will be correlated with eosinophil counts along with endoscopy findings, treatment outcomes and clinical measures of the disease such as symptoms, atopic co-morbidities, and demographics.
Biospecimen Retention: Samples With DNA
The investigators collected biopsies, blood, and urine from enrolled participants.
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| Ages Eligible for Study: | 1 Year to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Any patient undergoing a clinically indicated upper endoscopy with biopsy for suspected esophageal inflammation or esophageal disease, or who has histologically confirmed esophageal inflammation may be asked to enroll in this study. The investigators plan to recruit subjects for two years, and enroll up to 150 patients. The patients with a confirmed diagnosis of EoE will be followed in the study for two years after enrollment.
Criteria
Inclusion Criteria:
- Patient ages 1-18 undergoing upper endoscopy for suspected esophageal disease or esophageal inflammation or has histologically confirmed esophageal inflammation may be included in this study
Exclusion Criteria:
- Patients with a history or current diagnosis of esophageal malignancy or subjects with graft versus host disease will be excluded from the study.
- Patients that are considered at high risk for biopsies at the discretion of the child's physician and/or the researcher
- Patients with known bleeding disorders or patients with illnesses where bleeding would pose a threat to their health
- Diagnosis other than Eosinophilic Esophagitis (EoE) i.e. Inflammatory Bowel Disease (IBD), Gastroesophageal Reflux Disease (GERD)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822325
Locations
| United States, Illinois | |
| Ann & Robert H Lurie Childjren's Hospital of Chicago | |
| Chicago, Illinois, United States, 60611 | |
| University of Illinois at Chicago (UIC) | |
| Chicago, Illinois, United States, 60612 | |
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
| Principal Investigator: | Amir Kagalwalla, MD | Ann & Robert H. Lurie Children's Hopsital | |
| Principal Investigator: | Joshua Wechsler, MD | Ann & Robert H Lurie Children's Hospital of Chicago | |
| Principal Investigator: | Barry Wershil, MD | Ann & Robert H. Lurie Children's Hospital fo Chicago |
Additional Information:
Publications:
Publications:
| Responsible Party: | Joshua Wechsler, Attending Physician, Gastroenterology, Hepatology & Nutrition, Ann & Robert H Lurie Children's Hospital of Chicago |
| ClinicalTrials.gov Identifier: | NCT03822325 |
| Other Study ID Numbers: |
2010-14155 |
| First Posted: | January 30, 2019 Key Record Dates |
| Last Update Posted: | February 7, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Esophagitis Eosinophilic Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |
Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |