Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-02-01 @ 3:20 AM
Study NCT ID:
NCT03069495
Status:
TERMINATED
Last Update Posted:
2023-08-28
First Post:
2017-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Circulating Innate Lymphoid Cells in Allergic Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D014581', 'term': 'Urticaria'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'A one time blood draw'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Lack of research assistant to work on study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2017-02-22', 'studyFirstSubmitQcDate': '2017-02-27', 'lastUpdatePostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ILC2 Phenotype', 'timeFrame': '52 weeks', 'description': 'Blood ILC2s responsiveness will be determined solely for research purposes using ex vivo stimulation assays.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allergy', 'Asthma', 'Urticaria'], 'conditions': ['Allergy', 'Asthma', 'Urticaria']}, 'descriptionModule': {'briefSummary': 'This study evaluates blood type 2 innate lymphoid cells in participants with mild to moderate asthma and participants with chronic urticaria as compared to healthy adult participants.', 'detailedDescription': 'The first objective of this study is to determine whether blood ILC2s differ in female vs. male allergic asthmatics. This is because females become more susceptible to asthma after puberty and experience more severe disease as adults.\n\nThe second objective of this study is to determine whether ILC2 cells in chronic urticaria differ from healthy controls.\n\nThere will be one shared healthy control adult subject group for comparison for objective 1 and 2.\n\nIn this study, there will be a blood draw once on 3 different adult populations aged 19-50 years: 1) Participants with mild-to moderate allergic asthma; 2) Participants with chronic urticaria, and 3) Healthy control adult participants. Demographics and allergy indicators will be collected from the medical chart. The investigators will acquire whole blood for serum and acquisition of specific lymphocyte populations. There will be no intervention or research follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult subjects age 19-50 years.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult subjects between age 19-50 years.\n2. Non-smokers, defined as \\< 100 cigarettes in lifetime.\n\nExclusion Criteria:\n\n1. Female donors will be excluded if they are menopausal or have undergone total abdominal hysterectomy and/or bilateral salpingoophorectomy\n2. For female donors, blood draw cannot occur during menstrual period time. Subjects will be excluded if they have menstrual period at timing of blood draw.\n3. Current and past smokers.\n4. Subjects with asthma and any other lung disease including chronic obstructive pulmonary disease, interstitial lung disease, pulmonary hypertension, sarcoidosis, cystic fibrosis.\n5. Pregnant or lactating subjects\n6. Subjects with hypercalcemia (\\> 10.3 mg/dL), renal insufficiency (glomerular filtration rate \\[GFR\\] \\< 50 mL/min/1.73m2), or malignancy.\n7. Subjects with any symptoms of respiratory infection in the past 4 weeks.\n8. Subjects unable to hold leukotriene modifiers or antihistamines for at least 24 hours prior to blood draw.\n9. Subjects on any immunomodulators, including omalizumab, or systemic corticosteroid in the past 4 weeks.'}, 'identificationModule': {'nctId': 'NCT03069495', 'briefTitle': 'Role of Circulating Innate Lymphoid Cells in Allergic Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Role of Circulating Innate Lymphoid Cells in Allergic Disorders', 'orgStudyIdInfo': {'id': '0197-17-EP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Control Adult Subjects', 'description': 'Healthy adult subjects between the ages of 19-50 years will be enrolled.'}, {'label': 'Asthmatic Adult Subjects', 'description': 'Adult subjects between the ages of 19-50 years with mild-to-moderate asthma seen within the UNMC Allergy and Pulmonary Clinics will be invited to be enrolled.'}, {'label': 'Chronic Urticaria Adult Subjects', 'description': 'Adult subjects between the ages of 19-50 years with chronic urticaria seen within the UNMC Allergy Clinics will be invited to be enrolled.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Jill A Poole, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Subject information will be de-identified. IPD will not be made available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}