Stem Cell Related Donor Safety Study
Status: | Completed |
---|---|
Conditions: | Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 6/15/2017 |
Start Date: | January 2010 |
End Date: | September 2016 |
A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
52
sites
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
616.391.9000
Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Kosair Children's Hospital For more than a century, Kosair Children's Hospital and its predecessor hospitals...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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University of Utah Research is a major component in the life of the U benefiting...
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
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