Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-28 @ 5:47 AM
Study NCT ID:
NCT00926692
Status:
COMPLETED
Last Update Posted:
2015-08-26
First Post:
2009-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigations Regarding B-cell Subsets in Humans
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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-24', 'studyFirstSubmitDate': '2009-06-19', 'studyFirstSubmitQcDate': '2009-06-22', 'lastUpdatePostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of B-1 cells in humans', 'timeFrame': 'determined over the years study in effect', 'description': 'an equivalent cell type was isolated in humans'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['B-cells', 'CD5+', 'B1 Cells', 'Healthy Controls'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The aim of this research is to define the human equivalent of mouse B1 cells.', 'detailedDescription': 'The specific aim of this research project is to define the human equivalent of mouse B1 cells. This will be done by evaluating IgM secretion, surface markers, functional characteristics, V gene usage, N-region addition, and phosphorylation status of intracellular proteins, gene expression, sequencing of immunoglobulin genes, determination of antigenic specificity, replication history, and response to different stimuli.\n\nThe goal of this project is to begin to the translation of decades of basic science research and research in the mouse model into the human system. It is believed that properly defining this B cell subset in humans will lead to better therapeutics, prognostics and prevention for a number of disease including infections, autoimmune disease, and cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Control Population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is considered by the physician to be a healthy adult.\n\nExclusion Criteria:\n\n* Subject is under the age of 18\n* Subject has an infection or is currently ill'}, 'identificationModule': {'nctId': 'NCT00926692', 'briefTitle': 'Investigations Regarding B-cell Subsets in Humans', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Investigations Regarding B-cell Subsets in Humans', 'orgStudyIdInfo': {'id': 'GCRC 0266'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Subjects', 'description': 'All subjects are considered healthy', 'interventionNames': ['Other: Blood draw']}], 'interventions': [{'name': 'Blood draw', 'type': 'OTHER', 'description': 'Subject will have blood draw.', 'armGroupLabels': ['Healthy Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Feinstein Institute for Medical Research', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}], 'overallOfficials': [{'name': 'Daniel Griffin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Feinstein Institute for Medical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow Infectious Diseases', 'investigatorFullName': 'Daniel Griffin', 'investigatorAffiliation': 'Northwell Health'}}}}