Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-05 @ 5:44 PM
Study NCT ID:
NCT03937804
Status:
COMPLETED
Last Update Posted:
2025-12-24
First Post:
2019-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Approaches for Empowering Studies of Asthma in Populations of African Descent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'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': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08-21', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2019-05-03', 'studyFirstSubmitQcDate': '2019-05-03', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expand and integrate multi-omic resources for asthma research in African Diaspora populations and identify novel genetic determinants for risk of asthma in CAAPA cohorts', 'timeFrame': 'single assessment', 'description': 'Expand and integrate multi-omic resources for asthma research in African Diaspora populations and identify novel genetic determinants for risk of asthma in CAAPA cohorts'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trans-omics', 'Natural History'], 'conditions': ['Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2019-HG-0092.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nSome groups of people have a high prevalence of asthma and allergic disease. Also, asthma and allergic disease are often found in several members of the same family. Researchers want to learn more about what factors might cause asthma, both genetic and environmental.\n\nObjective:\n\nTo build a collection of information to try to find genes that cause conditions and disorders such as asthma and allergic disease.\n\nEligibility:\n\nPeople ages 18 99 of self-identified African, African American, or African Caribbean descent who either have no history of asthma or wheeze or have a physician s diagnosis of asthma\n\nDesign:\n\nParticipants will be screened with an interview by phone or in person.\n\nParticipants will fill out a questionnaire about their general health and exposure to allergens and smoke.\n\nParticipants will have a physical exam.\n\nParticipants will have blood tests.\n\nParticipants will provide a skin cell sample. Up to two samples will be taken from the inside of the nose. A brush will be used to take the samples.\n\nParticipants will have a breathing test. They will be asked to blow forcefully 3 or more times into a lung function machine.\n\nParticipants may have their blood and skin samples sent to a lab. DNA will be extracted from the samples and tested.\n\nParticipants blood and skin samples will be stored. Samples may be used in future research studies.\n\n...', 'detailedDescription': 'Asthma is a complex disease where the interplay between genetic factors and environmental exposures controls susceptibility and disease progression. In the U.S., there remains an epidemic of asthma that disproportionately affects underrepresented minorities and creates a major public health burden, especially among children. Asthmatics of African ancestry continue to have more severe asthma and more severe clinical symptoms than their non-African counterparts, but few studies have focused on this vulnerable group. The purpose of this study is to expand our previous study, the Consortium on Asthma among African-ancestry Populations in the Americas (CAAPA) to integrate multi-omic resources for asthma research in African Diaspora populations and by recruiting new participants. The protocol described herein refers to the recruitment that will take place at the NIH Clinical Center as part of the expansion of CAAPA (CAAPA2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'African American adults with asthma and healthy controls', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nIndividuals age 18 to 99 of self-identified African, African American, or African Caribbean ancestry who either have no history of asthma or wheeze (controls) or have a physician s diagnosis of asthma. This study focuses exclusively on African ancestry individuals in order to address a lack in the field of asthma research focusing on those of African ancestry despite the greater disease burden experienced by these individuals. Enrollment for the CAAPA2 study at the NIH CC will include only adults, while children will be enrolled at other CAAPA2 sites, consistent with expertise at those sites.\n\nEXCLUSION CRITERIA:\n\n* First degree relative of enrolled study participant (as determined through responses to a screening questionnaire to question on participation of parents, siblings, or half-siblings)\n* Current and active smoker\n* History of: chronic obstructive pulmonary disease, chronic obstructive airway disease, emphysema, chronic bronchitis, lung transplant, kyphoscoliosis, sarcoidosis, bronchopulmonary dysplasia, cystic fibrosis, bronchiectasis, rheumatoid arthritis, Crohn s disease, psoriasis, carcinoma of the lung, ciliary dyskinesia, lupus, or active tuberculosis\n* Having any medical illnesses that would increase the risk that the participant would incur by participating in the study, interfere with the outcomes of the study, or interfere with the study procedures (evaluated using Spirometry Screener.)\n* Current or previous COVID-19 infection\n* Pregnant women: while study procedures are all minimal risk, the inclusion of pregnant women is not necessary to address the research questions. Additionally, pregnancy may affect some of our parameters of interest (particularly gene expression) in unpredictable ways and the size of the growing fetus may introduce mechanical challenges to optimal performance of pulmonary function tests at later stages of pregnancy. Exclusion will be based on self-report during screening.'}, 'identificationModule': {'nctId': 'NCT03937804', 'briefTitle': 'New Approaches for Empowering Studies of Asthma in Populations of African Descent', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'New Approaches for Empowering Studies of Asthma in Populations of African Descent', 'orgStudyIdInfo': {'id': '190092'}, 'secondaryIdInfos': [{'id': '19-HG-0092'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'asthmatics', 'description': 'persons with asthma'}, {'label': 'control', 'description': 'persons without asthma'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Charles N Rotimi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Human Genome Research Institute (NHGRI)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'IPD has been shared with CAAPA2 Investigators at the time of collection. Data will be deposited in repositories and/or with journals at the time of publication.', 'ipdSharing': 'YES', 'description': 'All collected IPD to be shared with CAAPA2 research team. De-identified IPD to be shared with CAAPA2 investigators. De-identified IPD will be shared with appropriate NIH-sponsored databases such as dbGAP and data underlying a publication may be shared with a journal requiring it for publication.', 'accessCriteria': 'Other CAAPA2 Investigators from the Consortium may request access to de-identified data from all CAAPA2 sites (including this one) with an analysis plan (association studies or omics analyses) that is approved by the research team. Data shared with repositories will be controlled-access and require IRB approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Human Genome Research Institute (NHGRI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}