Ignite Creation Date:
2025-12-25 @ 4:37 AM
Ignite Modification Date:
2026-03-03 @ 2:41 PM
Study NCT ID:
NCT02523118
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2015-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}, {'id': 'C535952', 'term': 'Eosinophilic enteropathy'}], 'ancestors': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2051-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2015-06-22', 'studyFirstSubmitQcDate': '2015-08-12', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2050-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mucosal eosinophilia (eos/hpf)', 'timeFrame': 'Duration of funding, at least 10 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Eosinophilic Gastrointestinal Disorders (EGIDs)', 'Eosinophilic Esophagitis', 'Eosinophilic Gastritis', 'Eosinophilic Gastroenteritis', 'Eosinophilic Colitis']}, 'referencesModule': {'references': [{'pmid': '34062314', 'type': 'DERIVED', 'citation': 'Safroneeva E, Pan Z, King E, Martin LJ, Collins MH, Yang GY, Capocelli KE, Arva NC, Abonia JP, Atkins D, Bonis PA, Dellon ES, Falk GW, Gonsalves N, Gupta SK, Hirano I, Leung J, Menard-Katcher PA, Mukkada VA, Schoepfer AM, Spergel JM, Wershil BK, Rothenberg ME, Aceves SS, Furuta GT; Consortium of Eosinophilic Gastrointestinal Disease Researchers. Long-Lasting Dissociation of Esophageal Eosinophilia and Symptoms After Dilation in Adults With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2022 Apr;20(4):766-775.e4. doi: 10.1016/j.cgh.2021.05.049. Epub 2021 May 29.'}], 'seeAlsoLinks': [{'url': 'https://www.rarediseasesnetwork.org/cms/CEGIR', 'label': 'Learn more about CEGIR at this website.'}]}, 'descriptionModule': {'briefSummary': '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 EoE, EoG, EoN and EoC normally undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis. Treatments are then decided based on how the cells look. 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.', 'detailedDescription': 'This is a longitudinal observational study in which individuals (males and females 3 years of age and greater) with EoE, EoG, EoN and EoC 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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Males and females ages 3 or greater with EoE, EoG, EoN or EoC.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females 3 years of age and older\n* Mucosal eosinophilia:\n\nEoE ≥ 15 eosinophils/HPF in the distal or proximal esophagus EoG ≥ 30 eosinophils/HPF in 5 HPF\\'s in the body and/or antrum EoN ≥ 53 eosinophils/HPF in the duodenum and/or ≥ 56 eosinophils/HPF in the jejunum and/or ileum EoC ≥ 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\n\n\\- Presence of symptoms is required for patients who are newly diagnosed but not required for patients who were previously diagnosed.\n\nExclusion Criteria:\n\n* History of intestinal surgery other than G tube placement\n* Enrolled in a blinded investigational study at the time of the first study visit\n* Have esophageal stricture (\\<3mm)\n* 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)'}, 'identificationModule': {'nctId': 'NCT02523118', 'acronym': 'OMEGA', 'briefTitle': 'OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': '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 (EoG), Enteritis (EoN) and Colitis (EoC)', 'orgStudyIdInfo': {'id': '2015-2311'}, 'secondaryIdInfos': [{'id': 'U54AI117870', 'type': 'OTHER_GRANT', 'domain': 'NIDDK'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Renee Nunez', 'role': 'CONTACT', 'email': 'nunez.renee@mayo.edu', 'phone': '480-301-4992'}, {'name': 'Benjamin Wright, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Allison Bruton', 'role': 'CONTACT', 'email': 'CongletonAL@archildrens.org', 'phone': '501-364-1060'}, {'name': 'Robert Pesek, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Arkansas Children's Research Institute", 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kira Chaiboonma', 'role': 'CONTACT', 'email': 'kchaiboonma@health.ucsd.edu', 'phone': '(858)-966-1700', 'phoneExt': '226884'}, {'name': 'Seema Aceves, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Rady Children's Hospital", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Keanna Capener', 'role': 'CONTACT', 'email': 'keanna.capener@cuanschutz.edu', 'phone': '303-724-8974'}, {'name': 'Paul Menard-Katcher, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Andrews', 'role': 'CONTACT', 'email': 'rachel.andrews@childrenscolorado.org', 'phone': '(720) 777-1994'}, {'name': 'Glenn Furuta, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60208', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tenesha Thomas', 'role': 'CONTACT', 'email': 'tenesha.thomas@northwestern.edu'}, {'name': 'Ikuo Hirano, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Riordan', 'role': 'CONTACT', 'email': 'mriordan@luriechildrens.org', 'phone': '312-227-4558'}, {'name': 'Joshua Wechsler, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Ann and Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'COMPLETED', 'country': 'United States', 'facility': "Riley Children's Hospital", 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Perla Adames-Castillo', 'role': 'CONTACT', 'email': 'perla.adamescastillo@nih.gov'}, {'name': 'Paneez Khoury, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Institutes of Health (NIH)', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Tufts University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jaimie Gowatsky', 'role': 'CONTACT', 'email': 'jaimie.gowatsky@mssm.edu', 'phone': '212-241-4908'}, {'name': 'Mirna Chehade, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lucas Plott', 'role': 'CONTACT', 'email': 'lucas_plott@med.unc.edu', 'phone': '919-966-8559'}, {'name': 'Evan Dellon, M.D., MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of North Carolina, Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bliss Magella', 'role': 'CONTACT', 'email': 'bliss.magella@cchmc.org', 'phone': '513-636-7832'}, {'name': 'Marc E. Rothenberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ignacio De La Torre', 'role': 'CONTACT', 'email': 'delatorrei@chop.edu', 'phone': '215-590-6187'}, {'name': 'Jonathan Spergel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erin Lee', 'role': 'CONTACT', 'email': 'Erin.Lee1@pennmedicine.upenn.edu', 'phone': '215-662-2493'}, {'name': 'Maureen DeMarshall', 'role': 'CONTACT', 'email': 'demarshm@mail.med.upenn.edu', 'phone': '215-349-8546'}, {'name': 'Kristle Lynch, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Regina Tyree', 'role': 'CONTACT', 'email': 'regina.n.tyree@vumc.org', 'phone': '(615) 343-6845'}, {'name': 'Girish Hiremath, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amanda Vega', 'role': 'CONTACT', 'email': 'amandav@bcm.edu', 'phone': '832-824-0939'}, {'name': 'Daisy Vita (Tran)', 'role': 'CONTACT', 'email': 'dxtran1@texaschildrens.org', 'phone': '(832)-824-3640'}, {'name': 'Carla Davis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Baylor College of Medicine & Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sophia Schuman', 'role': 'CONTACT', 'email': 'sophia.schuman@hsc.utah.edu', 'phone': '801-585-0894'}, {'name': 'Kathryn Peterson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Bliss Magella', 'role': 'CONTACT', 'email': 'bliss.magella@cchmc.org', 'phone': '513-636-7832'}], 'overallOfficials': [{'name': 'Marc E Rothenberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cincinnati Children's Hospital Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'ORDR', 'class': 'UNKNOWN'}, {'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}