Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-28 @ 4:49 PM
Study NCT ID:
NCT00717535
Status:
WITHDRAWN
Last Update Posted:
2013-04-29
First Post:
2008-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying Umbilical Cord Blood From African-American Donors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D015925', 'term': 'Cryopreservation'}], 'ancestors': [{'id': 'D014021', 'term': 'Tissue Preservation'}, {'id': 'D016591', 'term': 'Histocytological Preparation Techniques'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D011309', 'term': 'Preservation, Biological'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Cord blood unit (CBU)will be collected in utero and transported to the Stem Cell Processing Laboratory. The volume of the CBU will be measured and cell count will be obtained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding unavailable', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-25', 'studyFirstSubmitDate': '2008-07-16', 'studyFirstSubmitQcDate': '2008-07-16', 'lastUpdatePostDateStruct': {'date': '2013-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between total nucleated cell yield of cord blood units and gestational history, maternal history, and delivery information', 'timeFrame': 'Within a year'}, {'measure': 'Improvement in total nucleated cell yield of cord blood units from African-American donors', 'timeFrame': 'Within a year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['health status unknown'], 'conditions': ['Health Status Unknown']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying umbilical cord blood in the laboratory and gathering information about current and previous pregnancies from African-American umbilical cord blood donors may help doctors learn more about the umbilical cord blood of these donors.\n\nPURPOSE: This clinical trial is looking at umbilical cord blood from African-American donors.', 'detailedDescription': 'OBJECTIVES:\n\n* To correlate the total nucleated cell yield of cord blood units from African-American cord blood donors with gestational history, maternal history, and delivery information.\n\nOUTLINE: This is a multicenter study.\n\nDonors complete questionnaires about their demographics, maternal history, gestational history, and delivery. Cord blood units (CBU) are collected in utero and transported to the Stem Cell Processing Laboratory where they are evaluated for CBU volume and cell count (i.e., total nucleated cell yield) and cryopreserved. The study results will then be used to devise future interventional strategies to improve the yield of nucleated cells of CBU.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'African American cord blood donors', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* African-American participant in the National Marrow Donor Program cord blood collection protocol C-2844\n* Recruited from the Labor and Delivery Suites of the Detroit Medical Center or its affiliated sites\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00717535', 'briefTitle': 'Studying Umbilical Cord Blood From African-American Donors', 'organization': {'class': 'OTHER', 'fullName': 'Barbara Ann Karmanos Cancer Institute'}, 'officialTitle': 'Investigation of the Total Nucleated Cell Yield of Cord Blood Units Collected From African-American Donors in Correlation With Gestational and Other Health Variables', 'orgStudyIdInfo': {'id': 'CDR0000598111'}, 'secondaryIdInfos': [{'id': 'P30CA022453', 'link': 'https://reporter.nih.gov/quickSearch/P30CA022453', 'type': 'NIH'}, {'id': 'WSU-C-2933'}, {'id': 'WSU-W81XWH-05-1-0266'}, {'id': 'WSU-024405MP4E', 'type': 'OTHER', 'domain': 'Wayne State University - Human Investigation Committee'}, {'id': 'WSU-0505001823', 'type': 'OTHER', 'domain': 'Wayne State University - Human Investigation Committee'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cryopreservation', 'type': 'OTHER'}, {'name': 'questionnaire administration', 'type': 'OTHER'}, {'name': 'study of socioeconomic and demographic variables', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Voravit Ratanatharathorn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barbara Ann Karmanos Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barbara Ann Karmanos Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}