RECRUITING

OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2015-07-17
Study Completion:2051-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02523118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males or females 3 years of age and older
  2. * Mucosal eosinophilia:
  1. * History of intestinal surgery other than G tube placement
  2. * Enrolled in a blinded investigational study at the time of the first study visit
  3. * Have esophageal stricture (\<3mm)
  4. * Have other identifiable causes for eosinophilia (except Inflammatory Bowel Disease): infections, Gastrointestinal (GI) cancer, other GI inflammatory disease (e.g., Ulcerative Colitis or Crohn\'s Disease)

Contacts and Locations

Study Contact

Lauren Turner, MPH
CONTACT
513-803-5446
Lauren.Turner@cchmc.org

Principal Investigator

Marc E Rothenberg, MD, PhD
PRINCIPAL_INVESTIGATOR
Cincinnati Children's Hospital Medical Center

Study Locations (Sites)

Mayo Clinic Hospital
Phoenix, Arizona, 85054
United States
Arkansas Children's Research Institute
Rogers, Arkansas, 72758
United States
Rady Children's Hospital
San Diego, California, 92123
United States
University of Colorado Denver
Aurora, Colorado, 80045
United States
Children's Hospital Colorado
Denver, Colorado, 80218
United States
Northwestern University
Chicago, Illinois, 60208
United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Riley Children's Hospital
Indianapolis, Indiana, 46202
United States
National Institutes of Health (NIH)
Bethesda, Maryland, 20892
United States
Tufts University
Boston, Massachusetts, 02111
United States
Mayo Clinic
Rochester, Minnesota, 55902
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Baylor College of Medicine & Texas Children's Hospital
Houston, Texas, 77030
United States
University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Marc E Rothenberg, MD, PhD, PRINCIPAL_INVESTIGATOR, Cincinnati Children's Hospital Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-07-17
Study Completion Date2051-01-01

Study Record Updates

Study Start Date2015-07-17
Study Completion Date2051-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Eosinophilic Gastrointestinal Disorders (EGIDs)
  • Eosinophilic Esophagitis
  • Eosinophilic Gastritis
  • Eosinophilic Gastroenteritis
  • Eosinophilic Colitis