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

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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.


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
3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
403
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Sioux Falls, SD
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
1443
mi
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Boston, MA
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
1057
mi
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Buffalo, NY
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
1038
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Chapel Hill, NC
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
609
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Chicago, IL
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
898
mi
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Cleveland, OH
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
616.391.9000
Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
733
mi
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Grand Rapids, MI
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
571
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Jackson, MS
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231 E Chestnut St
Louisville, Kentucky 40202
(502) 629-6000
Kosair Children's Hospital For more than a century, Kosair Children's Hospital and its predecessor hospitals...
661
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Louisville, KY
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
552
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Minneapolis, MN
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
1225
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
1383
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
777
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
1410
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Ann Arbor, Michigan 48109
828
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
803
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Atlanta, Georgia 30322
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Beech Grove, Indiana 46107
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Chicago, Illinois 60014
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Cincinnati, Ohio 45236
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899
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Cleveland, OH
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
349
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Detroit, Michigan 48201
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Detroit, MI
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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1285
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Hackensack, NJ
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500 University Dr
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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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Iowa City, Iowa 52242
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Iowa City, IA
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Kansas City, Missouri 64108
197
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Lake Success, New York 11042
1303
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
574
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Madison, WI
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
636
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New Hyde Park, New York 11040
1303
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New Hyde Park, NY
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New York, New York 10029
1290
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New York, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
1289
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940 NE 13th St
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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Orlando, Florida 32804
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Phoenix, Arizona 85006
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
1113
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
515
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Saint Petersburg, Florida 33701
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777
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Salt Lake City, UT
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San Antonio, Texas 78229
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San Diego, California 92093
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San Francisco, California 94143
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Tampa, Florida 33612
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Washington, D.C., District of Columbia
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Westwood, Kansas 66205
195
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1 Medical Center Blvd
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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Worcester, Massachusetts 01605
1406
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Worcester, MA
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