ClinicalTrials.gov
ClinicalTrials.gov Menu

Studying Umbilical Cord Blood From African-American Donors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00717535
Recruitment Status : Withdrawn (Funding unavailable)
First Posted : July 17, 2008
Last Update Posted : April 29, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Brief Summary:

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.

PURPOSE: This clinical trial is looking at umbilical cord blood from African-American donors.


Condition or disease Intervention/treatment
Health Status Unknown Other: cryopreservation Other: questionnaire administration Other: study of socioeconomic and demographic variables

Detailed Description:

OBJECTIVES:

  • 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.

OUTLINE: This is a multicenter study.

Donors 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.


Study Type : Observational
Actual Enrollment : 0 participants
Time Perspective: Prospective
Official Title: Investigation of the Total Nucleated Cell Yield of Cord Blood Units Collected From African-American Donors in Correlation With Gestational and Other Health Variables
Study Start Date : August 2005
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Correlation between total nucleated cell yield of cord blood units and gestational history, maternal history, and delivery information [ Time Frame: Within a year ]
  2. Improvement in total nucleated cell yield of cord blood units from African-American donors [ Time Frame: Within a year ]

Biospecimen Retention:   None Retained
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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
African American cord blood donors
Criteria

DISEASE CHARACTERISTICS:

  • African-American participant in the National Marrow Donor Program cord blood collection protocol C-2844
  • Recruited from the Labor and Delivery Suites of the Detroit Medical Center or its affiliated sites

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717535


Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Voravit Ratanatharathorn, MD Barbara Ann Karmanos Cancer Institute

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00717535     History of Changes
Other Study ID Numbers: CDR0000598111
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-C-2933
WSU-W81XWH-05-1-0266
WSU-024405MP4E ( Other Identifier: Wayne State University - Human Investigation Committee )
WSU-0505001823 ( Other Identifier: Wayne State University - Human Investigation Committee )
First Posted: July 17, 2008    Key Record Dates
Last Update Posted: April 29, 2013
Last Verified: April 2013

Keywords provided by Barbara Ann Karmanos Cancer Institute:
health status unknown