A Prospective, Multicenter Study to Compare and Validate Endoscopic, Histologic, Molecular, and Patient-Reported Outcomes in Pediatric and Adult Patients With Eosinophilic Esophagitis (EoE), Gastritis (EoG), Enteritis (EoN) and Colitis (EoC)
Status: Recruiting
Location: See all (19) locations...
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Healthy Volunteers: f
View:
• Males or females 3 years of age and older
• Mucosal eosinophilia:
⁃ 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.
Locations
United States
Arkansas
Arkansas Children's Research Institute
RECRUITING
Rogers
Arizona
Mayo Clinic Hospital
RECRUITING
Phoenix
California
Rady Children's Hospital
RECRUITING
San Diego
Colorado
University of Colorado Denver
RECRUITING
Aurora
Children's Hospital Colorado
RECRUITING
Denver
Illinois
Ann and Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Northwestern University
RECRUITING
Chicago
Indiana
Riley Children's Hospital
COMPLETED
Indianapolis
Massachusetts
Tufts University
COMPLETED
Boston
Maryland
National Institutes of Health (NIH)
RECRUITING
Bethesda
Minnesota
Mayo Clinic
COMPLETED
Rochester
North Carolina
University of North Carolina, Chapel Hill
RECRUITING
Chapel Hill
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Baylor College of Medicine & Texas Children's Hospital
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Advancing Translational Sciences (NCATS), ORDR
Leads: Children's Hospital Medical Center, Cincinnati