OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA)
|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.|
|ClinicalTrials.gov Identifier: NCT02523118|
Recruitment Status : Recruiting
First Posted : August 14, 2015
Last Update Posted : April 2, 2021
|Condition or disease|
|Eosinophilic Gastrointestinal Disorders (EGIDs) Eosinophilic Esophagitis Eosinophilic Gastritis Eosinophilic Gastroenteritis Eosinophilic Colitis|
This is a longitudinal observational study in which individuals (males and females 3 years of age and greater) with EoE, EG, EGE 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|
|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), Gastroenteritis (EGE) and Colitis (EC)|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2050|
|Estimated Study Completion Date :||January 2051|
- 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
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
|Contact: Heidi Poppendeck, MPHemail@example.com|
|Contact: Kara Kliewer, PhD||(513) 636-4821||Kara.Kliewer@cchmc.org|
|Principal Investigator:||Marc E Rothenberg, MD, PhD||Children's Hospital Medical Center, Cincinnati|