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| ID | Type | Description | Link |
|---|---|---|---|
| U54AI117870 | Other Grant/Funding Number | NIDDK |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| ORDR | UNKNOWN |
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The purpose of this observational study is to find the best measures to define how well a person with eosinophilic disorder is doing. People with EoE, EoG, EoN and EoC normally undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis. Treatments are then decided based on how the cells look. We are aiming to compare different tissue components such as inflammatory cell types with clinical symptoms. We want to see if scores on standard questionnaires can give us an idea how well the person is doing.
This is a longitudinal observational study in which individuals (males and females 3 years of age and greater) with EoE, EoG, EoN and EoC will be followed over the course of time to see if standard questionnaires can give us an idea of how well the person is doing.
Participants undergoing standard of care (normal, routine care) endoscopies and/or colonoscopies will have biopsies (small pieces of tissue from the GI tract normally collected during these procedures) collected and used for the research study. Participants will also complete questionnaires related to their symptoms and quality of life. Participants will be followed over the course of time and asked to complete the questionnaires at various time points throughout the study.
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| Measure | Description | Time Frame |
|---|---|---|
| Mucosal eosinophilia (eos/hpf) | Mucosal eosinophil levels are measured as eosinophils per high power field (eos/hpf). The primary outcome measure is to determine the change in mucosal eosinophil level (eos/hpf) and to determine if the change in mucosal eosinophil level in eos/hpf correlates with the change in scores on clinical outcome measure metrics. | Duration of funding, at least 10 years |
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Inclusion Criteria:
EoE ≥ 15 eosinophils/HPF in the distal or proximal esophagus EoG ≥ 30 eosinophils/HPF in 5 HPF's in the body and/or antrum EoN ≥ 53 eosinophils/HPF in the duodenum and/or ≥ 56 eosinophils/HPF in the jejunum and/or ileum EoC ≥ 84 eosinophils/HPF from the transverse or descending colon and/or ≥ 32 eosinophils/HPF from the rectosigmoid colon or a biopsy from any colonic location with ≥ 100 eosinophils/HPF
- Presence of symptoms is required for patients who are newly diagnosed but not required for patients who were previously diagnosed.
Exclusion Criteria:
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Males and females ages 3 or greater with EoE, EoG, EoN or EoC.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bliss Magella | Contact | 513-636-7832 | bliss.magella@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Marc E Rothenberg, MD, PhD | Cincinnati Children's Hospital Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital | Recruiting | Phoenix | Arizona | 85054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34062314 | Derived | Safroneeva E, Pan Z, King E, Martin LJ, Collins MH, Yang GY, Capocelli KE, Arva NC, Abonia JP, Atkins D, Bonis PA, Dellon ES, Falk GW, Gonsalves N, Gupta SK, Hirano I, Leung J, Menard-Katcher PA, Mukkada VA, Schoepfer AM, Spergel JM, Wershil BK, Rothenberg ME, Aceves SS, Furuta GT; Consortium of Eosinophilic Gastrointestinal Disease Researchers. Long-Lasting Dissociation of Esophageal Eosinophilia and Symptoms After Dilation in Adults With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2022 Apr;20(4):766-775.e4. doi: 10.1016/j.cgh.2021.05.049. Epub 2021 May 29. |
| Label | URL |
|---|---|
| Learn more about CEGIR at this website. | View source |
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| National Center for Advancing Translational Sciences (NCATS) |
| NIH |
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Biopsies from the gastrointestinal (GI) tract may be collected and used to learn more about eosinophilic gastrointestinal disorders. Genetic analysis may be performed on some of these samples.
| Arkansas Children's Research Institute | Recruiting | Rogers | Arkansas | 72758 | United States |
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| Rady Children's Hospital | Recruiting | San Diego | California | 92123 | United States |
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| University of Colorado Denver | Recruiting | Aurora | Colorado | 80045 | United States |
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| Children's Hospital Colorado | Recruiting | Denver | Colorado | 80218 | United States |
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| Northwestern University | Recruiting | Chicago | Illinois | 60208 | United States |
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| Ann and Robert H. Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
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| Riley Children's Hospital | Completed | Indianapolis | Indiana | 46202 | United States |
| National Institutes of Health (NIH) | Recruiting | Bethesda | Maryland | 20892 | United States |
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| Tufts University | Completed | Boston | Massachusetts | 02111 | United States |
| Mayo Clinic | Completed | Rochester | Minnesota | 55902 | United States |
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| University of North Carolina, Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
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| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Baylor College of Medicine & Texas Children's Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
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| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| C535952 | Eosinophilic enteropathy |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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