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Trial record 6 of 67 for:    Recruiting, Not yet recruiting, Available Studies | digestive disease | NIDDK

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

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ClinicalTrials.gov Identifier: NCT02523118
Recruitment Status : Recruiting
First Posted : August 14, 2015
Last Update Posted : September 24, 2018
Sponsor:
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

Brief 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 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 or disease
Eosinophilic Gastrointestinal Disorders (EGIDs) Eosinophilic Esophagitis Eosinophilic Gastritis Eosinophilic Colitis

Detailed Description:

This is a longitudinal observational study in which individuals (males and females 3 years of age and greater) 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.


Study Type : Observational
Estimated Enrollment : 1050 participants
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)
Study Start Date : July 2015
Estimated Primary Completion Date : December 2050
Estimated Study Completion Date : January 2051

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Males and females ages 3 or greater with EoE, EG, or EC

*This study is currently not enrolling EoE patients and only enrolling patients with a primary EG and/or EC diagnosis.

Criteria

Inclusion Criteria:

  • Males or females 3 years of age and older
  • Mucosal eosinophilia (≥15 eos/hpf for EoE, ≥30 eos/hpf for EG, ≥32 eos/hpf for EC)
  • Presence of symptoms is required for patients who are newly diagnosed but not required for patients who were previously diagnosed
  • EC patients must have a history of one of the following at the time of colonoscopy:

    1. anemia
    2. peripheral eosinophilia
    3. hemoccult positive stool
    4. EGID
    5. allergic disease (allergic rhinitis, asthma, food allergy, eczema or other allergic features suggestive of atopic disease)

Exclusion Criteria:

  • History of intestinal surgery other than G tube placement
  • Enrolled in a blinded investigational study
  • Have esophageal stricture (<3mm)
  • 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)

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: Heidi Poppendeck, MPH 513-803-3078 heidi.poppendeck@cchmc.org
Contact: Kara Kliewer, PhD (513) 636-4821 Kara.Kliewer@cchmc.org

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Lea Jacinto    858-657-5131    Ljacinto@ucsd.edu   
Principal Investigator: Seema Aceves, M.D., PhD         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Jonathan Cahoon    303-724-8974    jonathan.cahoon@ucdenver.edu   
Principal Investigator: Paul Menard-Katcher, MD         
Children's Hospital Colorado Recruiting
Denver, Colorado, United States, 80218
Contact: Cassandra Burger    720-777-5739    cassandra.burger@childrenscolorado.org   
Principal Investigator: Glenn Furuta, M.D.         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60208
Contact: Angelika Zalewski    312-695-4036    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: Katie Keeley    312-227-4546    kkeeley@luriechildrens.org   
Contact: Kristin Johnson       KrJohnson@luriechildrens.org   
Principal Investigator: Barry Wershil, M.D.         
University of Illinois at Peoria Recruiting
Peoria, Illinois, United States, 61637
Contact: Jeanne Welte    309-624-7552    Jeanne.M.Welte@osfhealthcare.org   
Principal Investigator: Sandeep Gupta, MD         
United States, Massachusetts
Tufts University Recruiting
Boston, Massachusetts, United States, 02111
Contact: Teresa Brown    617-636-4941    Tbrown6@tuftsmedicalcenter.org   
Principal Investigator: John Leung, M.D.         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Gabriela Mendoza    212-241-8780    gabriela.mendoza@mssm.edu   
Principal Investigator: Mirna Chehade, MD         
United States, North Carolina
University of North Carolina, Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Shiyan Shoyoye    919-843-0688    shoyoye@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: Heidi Poppendeck, MPH    513-803-3078    heidi.poppendeck@cchmc.org   
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Leah Wilkey    215-590-2549    wilkeyl@email.chop.edu   
Principal Investigator: Jonathan Spergel, MD, PhD         
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         
United States, Texas
Baylor College of Medicine & Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Munazza Noor    832-824-0939    munazza.noor@bcm.edu   
Principal Investigator: Carla Davis, MD         
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

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 Posted: August 14, 2015    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018

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