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OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA)

This study is currently recruiting participants.
Verified January 2017 by Children's Hospital Medical Center, Cincinnati
Sponsor:
ClinicalTrials.gov Identifier:
NCT02523118
First Posted: August 14, 2015
Last Update Posted: January 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Office of Rare Diseases (ORD)
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
  Purpose
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 eosinophilic esophagitis (EoE), eosinophilic gastritis (EG), and eosinophilic colitis (EC) normally undergo endoscopy and/or colonoscopy (scope down the throat or up the bottom) where tissue specimens are collected for microscopic analysis. Treatments are then decided based on how the tissue looks. 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.

Condition
Eosinophilic Gastrointestinal Disorders (EGIDs) Eosinophilic Esophagitis Eosinophilic Gastritis Eosinophilic Colitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Other
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 (EG) and Colitis (EC)

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Mucosal eosinophilia (eos/hpf) [ Time Frame: Duration of funding, approximately 5 years ]
    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.


Biospecimen Retention:   Samples With DNA
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.

Estimated Enrollment: 1050
Study Start Date: July 2015
Estimated Study Completion Date: January 2051
Estimated Primary Completion Date: December 2050 (Final data collection date for primary outcome measure)
Detailed Description:

This is a longitudinal observational study in which individuals (males and females between the ages of 3-65 years) with EoE, EG, and EC 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males and females between the ages of 3-65 years with EoE, EG, or EC
Criteria

Inclusion Criteria:

  • Males or females between 3-65 years of age
  • Presence of symptoms
  • Mucosal eosinophilia (≥15 eos/hpf for EoE, ≥30 eos/hpf for EG, ≥65 eos/hpf for EC)

Exclusion Criteria:

  • History of intestinal surgery
  • Enrolled in a blinded investigational study
  • Have esophageal stricture (<3mm)
  • Have other identifiable causes for eosinophilia, infections, Gastrointestinal (GI) cancer, other GI inflammatory disease
  Contacts and Locations
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): NCT02523118


Contacts
Contact: Melody Hess, MS 513-636-5540 melody.hess@cchmc.org
Contact: Jonathan Kuhl, BS 513-803-3078 jonathan.kuhl@cchmc.org

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Melissa Aquino    858-576-1700 ext 6884    maquino1@rchsd.org   
Principal Investigator: Seema Aceves, M.D., PhD         
United States, Colorado
Children's Hospital Colorado Recruiting
Denver, Colorado, United States, 80218
Contact: Susanna Kantor    720-777-4200    susanna.kantor@childrenscolorado.org   
Principal Investigator: Glenn Furuta, M.D.         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60208
Contact: Angelika Zalewski    312-695-4054    angelika.zalewski@northwestern.edu   
Principal Investigator: Ikuo Hirano, M.D.         
Ann and Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Jessica Ross       JNRoss@luriechildrens.org   
Contact: Kristin Johnson       KrJohnson@luriechildrens.org   
Principal Investigator: Barry Wershil, M.D.         
United States, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Anita Gupta    317-948-9227    anigupta@iu.edu   
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Cindy Sawyers    317-944-1421    clsawyer@iu.edu   
United States, Massachusetts
Tufts University School of Medicine Recruiting
Boston, Massachusetts, United States, 02111
Contact: Pedro Eman    617-636-4941    peman@tuftsmedicalcenter.org   
Principal Investigator: John Leung, M.D.         
Tufts University Recruiting
Boston, Massachusetts, United States, 02111
Contact: Pedro Eman    617-636-4941    peman@tuftsmedicalcenter.org   
Principal Investigator: John Leung, M.D.         
United States, North Carolina
University of North Carolina, Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Sarah McGee    919-966-4591    smcgee@med.unc.edu   
Principal Investigator: Evan Dellon, M.D., MPH         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Melody Hess       melody.hess@cchmc.org   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maureen Demarshall    215-349-8546    demarshm@mail.med.upenn.edu   
Principal Investigator: Gary Falk, M.D., MS         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Office of Rare Diseases (ORD)
National Center for Advancing Translational Science (NCATS)
Investigators
Principal Investigator: Marc E Rothenberg, MD, PhD Children's Hospital Medical Center, Cincinnati
  More Information

Additional Information:
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02523118     History of Changes
Other Study ID Numbers: 2015-2311
U54AI117870 ( Other Grant/Funding Number: NIDDK )
First Submitted: June 22, 2015
First Posted: August 14, 2015
Last Update Posted: January 23, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Colitis
Esophagitis
Eosinophilic Esophagitis
Gastritis
Digestive System Diseases
Gastrointestinal Diseases
Gastroenteritis
Colonic Diseases
Intestinal Diseases
Esophageal Diseases
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Stomach Diseases