Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1812 participants
OBSERVATIONAL
2010-01-31
2016-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Related Donors
Related Hematopoietic Stem Cell Donors
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 Criteria
* Donors providing unstimulated peripheral blood stem cells or lymphocytes
* Children less than or equal to 4 years of age
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
University of Utah
OTHER
University of Pittsburgh
OTHER
Center for International Blood and Marrow Transplant Research
NETWORK
Responsible Party
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Principal Investigators
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Michael A Pulsipher, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles
Locations
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Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
University of California, San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Florida Center for Cellular Therapy
Orlando, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Children's Memorial Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Indiana Blood and Marrow Transplantation, LLC
Beech Grove, Indiana, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Iowa Hospitals
Iowa City, Iowa, United States
University of Kansas Medical Center
Westwood, Kansas, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, United States
Helen DeVos Children's Hospital - Spectrum Health
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
John Theurer Cancer Center - Hackensack University Medcial Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
North Shore University Hospital
Lake Success, New York, United States
Cohen Children's Medical Center of NY
New Hyde Park, 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
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Jewish Hospital
Cincinnati, Ohio, United States
University Hospitals of Cleveland/Case Western
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Institute of Medicine and Surgery
San Antonio, Texas, United States
University of Utah, Primary Children's Medical Center
Salt Lake City, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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06-DON
Identifier Type: -
Identifier Source: org_study_id
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