Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-30 @ 3:16 AM
Study NCT ID:
NCT00567632
Status:
COMPLETED
Last Update Posted:
2011-01-17
First Post:
2007-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Generation of Standard Laboratory Values for Pneumococci Antibodies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'human serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-14', 'studyFirstSubmitDate': '2007-12-04', 'studyFirstSubmitQcDate': '2007-12-04', 'lastUpdatePostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sufficient samples to calculate reference values', 'timeFrame': '10(2006-10/2007)'}], 'secondaryOutcomes': [{'measure': 'sufficient samples to correlate with screening assay', 'timeFrame': '10/2006-10/2007'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pneumococci', 'Antibody', 'Standard laboratory values'], 'conditions': ['Reference Values']}, 'descriptionModule': {'briefSummary': 'The determination of reference values is a necessary basis for research and clinical routine testing for pneumococci antibodies', 'detailedDescription': 'This study is meant to determine specific pneumococcal antibodies stratified for age. The investigators also correlate our assay with the results from a commercially available pneumococcal screening ELISA (iGG1 and IgG2) in order to facilitate a screening for immunodeficiency, and to monitor the success of a performed immunization'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'any clinically and immunologically healthy subject of any age undergoing selective surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects undergoing elective surgery\n\nExclusion Criteria:\n\n* Chronic illness condition,\n* Immunodeficiency'}, 'identificationModule': {'nctId': 'NCT00567632', 'briefTitle': 'Generation of Standard Laboratory Values for Pneumococci Antibodies', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Generation of Standard Laboratory Values for Pneumococci Antibodies', 'orgStudyIdInfo': {'id': '1-Rose'}}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Goethe University, Department of Pulmonology', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Markus A Rose, M.D., Ph.D., M.P.H', 'role': 'STUDY_CHAIR', 'affiliation': 'Goethe University, childrens Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Markus A. Rose, ass. Professor of Paediatrics', 'oldOrganization': "Goethe University, Childrens' Hospital"}}}}