Studying Umbilical Cord Blood From African-American Donors

This study has been withdrawn prior to enrollment.
(Funding unavailable)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00717535
First received: July 16, 2008
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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 Intervention
Health Status Unknown
Other: cryopreservation
Other: questionnaire administration
Other: study of socioeconomic and demographic variables

Study Type: Observational
Study Design: 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

Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Correlation between total nucleated cell yield of cord blood units and gestational history, maternal history, and delivery information [ Time Frame: Within a year ] [ Designated as safety issue: No ]
  • Improvement in total nucleated cell yield of cord blood units from African-American donors [ Time Frame: Within a year ] [ Designated as safety issue: No ]

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.


Enrollment: 0
Study Start Date: August 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717535

Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Voravit Ratanatharathorn, MD Barbara Ann Karmanos Cancer Institute
  More Information

No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00717535     History of Changes
Other Study ID Numbers: CDR0000598111, P30CA022453, WSU-C-2933, WSU-W81XWH-05-1-0266, WSU-024405MP4E, WSU-0505001823
Study First Received: July 16, 2008
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 01, 2014