Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT04781218
Status:
WITHDRAWN
Last Update Posted:
2021-09-16
First Post:
2021-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ABC Science Collaborative Registry Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Study did not start', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-09', 'studyFirstSubmitDate': '2021-03-01', 'studyFirstSubmitQcDate': '2021-03-01', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants who enroll in the ABC Registry', 'timeFrame': 'Up to 5 years', 'description': 'Number of participants who enroll in the ABC Registry (e.g. are interested in participating in upcoming research studies, including those related to COVID-19).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID19']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://abcsciencecollaborative.org/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The ABC Registry is associated with Pro00107943 and provides a resource for collecting information on members of school communities both regionally in North and South Carolina, as well as nationally in the United States (U.S.) through the National Program, including children, parents, teachers, superintendents, and other staff; and children identified through clinical practice. The overall goals of the Registry are to collect data relevant to public health during the coronavirus 2019 (COVID-19) pandemic and to establish and engage school communities that may be eligible for participation in future research studies, including observational studies, as well as prospective COVID-19 trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'School community members, including students, parents, staff, etc.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant currently attends, is the parent of a student, works in, or works with a school that is participating in the ABC Science Collaborative, or participant is an adult or child who learned of the registry through clinical practice and is interested in participating in COVID-19 related research,\n* Participant or their parent/guardian has provided informed consent or assent, as applicable\n* Participant or their parent/guardian has downloaded the "ABC Science" App from the App store as a part of the ABC Science Collaborative and has agreed to the App\'s Terms of Use\n* Participant or their parent/guardian is able to speak and read English or Spanish\n\nExclusion Criteria:\n\n* There are no specific exclusion criteria for this registry. Participants must meet inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT04781218', 'briefTitle': 'ABC Science Collaborative Registry Study', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'ABC Science Collaborative Registry Study', 'orgStudyIdInfo': {'id': 'Pro00107036'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants enrolled in the registry', 'description': 'Participants enrolled in the registry will include school community members including students, parents, staff, etc.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kanecia Zimmerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}