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 : February 1, 2023
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|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)|
|Actual Study Start Date :||July 17, 2015|
|Estimated Primary Completion Date :||December 1, 2050|
|Estimated Study Completion Date :||January 1, 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
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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|
Males and females ages 3 or greater with EoE, EG, EGE or EC.
*This study is not currently enrolling EG patients but is accepting new EoE, EGE and EC patients for participation.
- Males or females 3 years of age and older
- Mucosal eosinophilia: EoE ≥ 15 eosinophils/HPF in the distal or proximal esophagus, EG ≥ 30 eosinophils/HPF in 5 HPF's in the body and/or antrum, EGE ≥ 53 eosinophils/HPF in the duodenum and/or ≥ 56 eosinophils/HPF in the jejunum and/or ileum, EC ≥ 84 eosinophils/HPF from the transverse or descending colon and/or ≥ 32 eosinophils/HPF from the rectosigmoid colon or a biopsy from any colonic location with ≥ 100 eosinophils/HPF
- Presence of symptoms is required for patients who are newly diagnosed but not required for patients who were previously diagnosed.
- History of intestinal surgery other than G tube placement
- Enrolled in a blinded investigational study at the time of the first study visit
- 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)
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: Kara Kliewer, PhD||513-636-4821||Kara.firstname.lastname@example.org|
|Principal Investigator:||Marc E Rothenberg, MD, PhD||Children's Hospital Medical Center, Cincinnati|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Children's Hospital Medical Center, Cincinnati|
|Other Study ID Numbers:||
U54AI117870 ( Other Grant/Funding Number: NIDDK )
|First Posted:||August 14, 2015 Key Record Dates|
|Last Update Posted:||February 1, 2023|
|Last Verified:||December 2022|
Digestive System Diseases
Immune System Diseases