Stem Cell Related Donor Safety Study
- Conditions
- Related Hematopoietic Stem Cell Donors
- Registration Number
- NCT00948636
- 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 unrelated hematopoietic stem cell donors.
The study will also assess the hypothesis that young (\<18 years) and older (\>60 years) related donors are at increased risk for toxicity associated with donation compared to younger adult donors by describing the adverse events reported in these populations.
An ancillary study of the psychological impact of donation on health-related quality of life (HRQoL) will enroll related donors and compare them to an age-matched normative cohort.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1812
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (52)
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
John Theurer Cancer Center - Hackensack University Medcial Center
🇺🇸Hackensack, New Jersey, United States
Children's Memorial Medical Center
🇺🇸Chicago, Illinois, United States
Children's National Medical Center
🇺🇸Washington, D.C., District of Columbia, United States
University Hospitals of Cleveland/Case Western
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
University of California, San Diego
🇺🇸San Diego, California, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Jewish Hospital
🇺🇸Cincinnati, Ohio, United States
Texas Institute of Medicine and Surgery
🇺🇸San Antonio, Texas, United States
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Barbara Ann Karmanos Cancer Center
🇺🇸Detroit, Michigan, United States
Mayo Clinic, Rochester
🇺🇸Rochester, Minnesota, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Indiana Blood and Marrow Transplantation, LLC
🇺🇸Beech Grove, Indiana, United States
University of Iowa Hospitals
🇺🇸Iowa City, Iowa, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Helen DeVos Children's Hospital - Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Children's Mercy Hospitals and Clinics
🇺🇸Kansas City, Missouri, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Cohen Children's Medical Center of NY
🇺🇸New Hyde Park, New York, United States
North Shore University Hospital
🇺🇸Lake Success, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Mt. Sinai Medical Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
University of Utah, Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Florida Center for Cellular Therapy
🇺🇸Orlando, Florida, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University of Kansas Medical Center
🇺🇸Westwood, Kansas, United States