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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 : June 9, 2020
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

Tracking Information
First Submitted Date June 22, 2015
First Posted Date August 14, 2015
Last Update Posted Date June 9, 2020
Study Start Date July 2015
Estimated Primary Completion Date December 2050   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 12, 2015)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
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)
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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.

Condition
  • Eosinophilic Gastrointestinal Disorders (EGIDs)
  • Eosinophilic Esophagitis
  • Eosinophilic Gastritis
  • Eosinophilic Colitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 12, 2015)
1050
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2051
Estimated Primary Completion Date December 2050   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Heidi Poppendeck, MPH 513-803-3078 heidi.poppendeck@cchmc.org
Contact: Kara Kliewer, PhD (513) 636-4821 Kara.Kliewer@cchmc.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02523118
Other Study ID Numbers 2015-2311
U54AI117870 ( Other Grant/Funding Number: NIDDK )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor Children's Hospital Medical Center, Cincinnati
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)
Investigators
Principal Investigator: Marc E Rothenberg, MD, PhD Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date June 2020