Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2026-01-09 @ 10:16 PM
Study NCT ID:
NCT01988805
Status:
WITHDRAWN
Last Update Posted:
2014-10-17
First Post:
2013-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene Polymorphism Study of Normal Individual Inflammasome Genes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-16', 'studyFirstSubmitDate': '2013-11-14', 'studyFirstSubmitQcDate': '2013-11-14', 'lastUpdatePostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'analyze their ability to respond to exogenous challenges by changing the production of proteins, the expression of genes and their ability to migrate and ingest materials', 'timeFrame': 'one visit', 'description': 'Our intent is to collect these cells, divide them into subtypes such as monocytes, lymphocytes and neutrophils and then to analyze their ability to respond to exogenous challenges by changing the production of proteins, the expression of genes and their ability to migrate and ingest materials. We additionally will be interested in examining the cell components that may be released from these cells during various in vitro challenges.'}]}, 'conditionsModule': {'conditions': ['Healthy Individuals']}, 'descriptionModule': {'briefSummary': 'This study is intended to collect blood from healthy individuals to investigate whether variations in immune-related (inflammasome) genes affect how the immune cells found in the blood can help fight infections and prevent diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Normal volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy with no chronic or acute illnesses, or taking medication which in the opinion of the PI would impact the analyses being conducted.\n2. At least 18 years or older.\n3. Are capable of reading, understanding and providing written informed consent.\n\nExclusion Criteria:\n\n1. Non-English speaking.\n2. Individuals under 18 years old.\n3. Woman who believe they are or may be pregnant. (Based on self reporting. Pregnancy testing will not be conducted for the purposes of this study)\n4. Individuals experiencing acute or chronic illnesses which in the opinion of the PI would impact the analyses being conducted.\n5. Currently taking prescription or over the counter medication which in the opinion of the PI would impact the analyses being conducted.\n6. Individual has donated blood more than twice in the last week or the amount to be drawn will exceed the maximum allowance in the last 8 weeks.'}, 'identificationModule': {'nctId': 'NCT01988805', 'briefTitle': 'Gene Polymorphism Study of Normal Individual Inflammasome Genes', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Immunological Characterization of Blood and Inflammasome Gene Segment Polymorphism Analysis of Normal Healthy Individuals', 'orgStudyIdInfo': {'id': '2012H0346'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Blood Draw', 'description': 'Normal healthy individuals will be consented and their blood drawn at the time of their visit.', 'interventionNames': ['Other: Blood Draw']}], 'interventions': [{'name': 'Blood Draw', 'type': 'OTHER', 'armGroupLabels': ['Blood Draw']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Davis Heart & Lung Research Institute', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Director, Pulmonary Research', 'investigatorFullName': 'Mark D. Wewers, MD', 'investigatorAffiliation': 'Ohio State University'}}}}