Status:
COMPLETED
Stem Cell Related Donor Safety Study
Lead Sponsor:
Center for International Blood and Marrow Transplant Research
Collaborating Sponsors:
National Institutes of Health (NIH)
University of Utah
Conditions:
Related Hematopoietic Stem Cell Donors
Eligibility:
All Genders
Brief Summary
The study tests the hypothesis that related hematopoietic stem cell donors are at a higher risk for acute medical and psychological toxicity associated with the donation process compared to adult unre...
Eligibility Criteria
Inclusion
- Donors of any age providing either a first or second BM or PBSC donation
- Meet donation criteria per institution policies and procedures
- Willing to receive phone follow-up at 1, 6, and 12 months
- Signed informed consent for study participation
- For the HRQoL ancillary study, inclusion criteria:
- Related donors age greater than or equal to 5, eligible and consented to the primary trial by the above listed inclusion criteria
- Donors competent to answer psychological assessment questions by themselves, or if a child, should be able to respond to psychological assessment questions and have an appropriate proxy also able to complete the HRQoL proxy interview
- English speaking
- Access to a telephone
- Willing to participate in pre-donation, 1 month and 1 year follow-up interviews
- Signed informed consent for study participation in ancillary study
Exclusion
- Per institutional guidelines
- Donors providing unstimulated peripheral blood stem cells or lymphocytes
- For the HRQoL ancillary study, exclusion criteria:
- Children less than or equal to 4 years of age
Key Trial Info
Start Date :
January 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
1812 Patients enrolled
Trial Details
Trial ID
NCT00948636
Start Date
January 1 2010
End Date
September 1 2016
Last Update
June 14 2017
Active Locations (52)
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1
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
2
University of California, San Diego
San Diego, California, United States, 92093
3
University of California, San Francisco
San Francisco, California, United States, 94143
4
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010