Trial record 1 of 1 for:    A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life
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Stem Cell Related Donor Safety Study (RDSafe)

This study is currently recruiting participants.
Verified May 2013 by Center for International Blood and Marrow Transplant Research
Sponsor:
Collaborators:
University of Utah
University of Pittsburgh
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:
NCT00948636
First received: July 28, 2009
Last updated: January 15, 2014
Last verified: May 2013
  Purpose

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.


Condition
Related Hematopoietic Stem Cell Donors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life

Further study details as provided by Center for International Blood and Marrow Transplant Research:

Estimated Enrollment: 2300
Study Start Date: January 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Related Donors
Related Hematopoietic Stem Cell Donors

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

participating institutions (transplant centers)

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948636

Contacts
Contact: Hati E kobusingye, MS 612-294-8345 hkobusin@nmdp.org
Contact: RaeAnne Besser 612-465-7847 rbesser@nmdp.org

  Hide Study Locations
Locations
United States, Arizona
Banner Good Samaritan Medical Center Terminated
Phoenix, Arizona, United States, 85006
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92093
Contact: Edward Ball, M.D.    858-822-6600    tball@ucsd.edu   
Contact: Sue Corringham    858-822-6387    scorringham@ucsd.edu   
Principal Investigator: Edward Ball, M.D.         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Christopher Dvorak, M.D.    415-476-2188    dvorakc@peds.ucsf.edu   
Contact: Jueleah Expose-Spencer       Jueleah.Expose-Spencer@ucsfmedctr.org   
Principal Investigator: Christopher Dvorak, M.D.         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: David Jacobsohn, MD    202-476-6250    dajacobs@childrensnational.org   
Contact: Lucy Lubinski, MS    202-476-6768    LLubinsk@cnmc.org   
Principal Investigator: David Jacobsohn, MD         
United States, Florida
Florida Center for Cellular Therapy Recruiting
Orlando, Florida, United States, 32804
Contact: Yasser Khaled, M.D.    407-303-5932    yasser.khaled.md@flhosp.org   
Contact: Tamica Silvers    407-303-2776    tamica.silvers@flhosp.org   
Principal Investigator: Vijay Reddy, M.D.         
All Children's Hospital Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Aleksandra Petrovic, MD    727-767-6851    aleksandra.petrovic@allkids.org   
Contact: Michael Gates, RN    727-767-4178    michael.gates@allkids.org   
Principal Investigator: Aleksandra Petrovic, MD         
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Marcie Tomblyn, MD    813-745-6284    marcie.tomblyn@moffitt.org   
Contact: Michelle Burton, RN    813-745-1537    michelle.burton@moffitt.org   
Principal Investigator: Marcie Tomblyn, MD         
United States, Georgia
Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Edmund Waller, M.D., PhD    404-727-4995    ewaller@emory.edu   
Contact: Sharon Joseph    404-778-5127    sharon.joseph2@emory.edu   
Principal Investigator: Edmund Waller, M.D., PhD         
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Ann Haight, M.D.    404-785-1191    ann.haight@choa.org   
Contact: Kristy Applegate    404-785-2125    Kristy.applegate@choa.org   
Principal Investigator: Ann Haight, M.D.         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Andrew Artz, M.D.    773-702-4400    aartz@medicine.bsd.uchicago.edu   
Contact: Linda Schroeder    773-834-0982    lschroed@medicine.bsd.uchicago.edu   
Principal Investigator: Andrew Artz, M.D.         
Children's Memorial Medical Center Recruiting
Chicago, Illinois, United States, 60014
Contact: William Tse, MD    773-755-6382    wtse@childrensmemorial.org   
Contact: Jessica Day    7738803459    JEday@childrensmemorial.org   
Principal Investigator: William Tse, MD         
United States, Indiana
Indiana Blood and Marrow Transplantation, LLC Recruiting
Beech Grove, Indiana, United States, 46107
Contact: Luke Akard, M.D.    317-865-5500    lakard@ibmtindy.com   
Contact: Elissa O'Malley    317-782-7296    eknezevich@ibmtindy.com   
Principal Investigator: Luke Akard, M.D.         
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Paul Haut, MD    317-274-7854    phaut@iupui.edu   
Contact: Courtney Spiegel    317-278-0581    clorch@iupui.edu   
Principal Investigator: Paul Haut, MD         
United States, Iowa
University of Iowa Hospitals Recruiting
Iowa City, Iowa, United States, 52242
Contact: Margarida Silverman, MD    319-384-9156    margarida-silverman@uiowa.edu   
Contact: Karen Parrott, RN, CRC    319-353-6347    karen-parrott@uiowa.edu   
Principal Investigator: Margarida Silverman, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Joseph McGuirk, DO    913-588-7750    jmcguirk@kumc.edu   
Contact: Kelly Daniels    913-588-4714    kdaniels2@kumc.edu   
Principal Investigator: Joseph McGuirk, DO         
United States, Kentucky
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Alexa Cheerva, M.D., M.S    502-852-8450    acchee01@louisville.edu   
Contact: Belinda Coy    502-852-8450    bgcoy001@louisville.edu   
Principal Investigator: Alexa Cheerva, M.D., M.S.         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Thomas Spitzer, MD    617-724-9191    tspitzer@partners.org   
Contact: Candace Del Rio       CDELRIO@PARTNERS.ORG   
Principal Investigator: Thomas Spitzer, MD         
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Jan Cerny, MD    774-442-3903    Jan.Cerny@umassmemorial.org   
Contact: Elizabeth Marble    508-856-2024    elizabeth.marble@umassmemorial.org   
Principal Investigator: Jan Cerny, MD         
United States, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: James Connelly, MD    734-647-5210    jaconnel@med.umich.edu   
Contact: Nancy McCullough    734-936-8538    ntsai@umich.edu   
Principal Investigator: James Connelly, MD         
Barbara Ann Karmanos Cancer Center Recruiting
Detroit, Michigan, United States, 48201
Contact: Muneer Abidi, MD    313-576-8713    abidim@karmanos.org   
Contact: Marie Ventimiglia    313-576-9271    ventimim@karmanos.org   
Principal Investigator: Muneer Abidi, MD         
Helen DeVos Children's Hospital - Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Aly Abdel-Mageed, MD    616-391-9127    aly.mageed@devoschildrens.org   
Contact: Virginia DeWitt    616-391-9364    virginia.dewitt@spectrum-health.org   
Principal Investigator: Aly Abdel-Mageed, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Daniel Weisdorf, MD    612-624-0123    weisd001@umn.edu   
Contact: Roby Nicklow, RN    612-624-9452    rnicklo1@fairview.org   
Principal Investigator: Daniel Weisdorf, MD         
Mayo Clinic, Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mark Litzow, M.D.    507-284-5362    litzow.mark@mayo.edu   
Contact: Stacy Anderson, RN    507-538-9552    anderson.stacy@mayo.edu   
Principal Investigator: Mark Litzow, M.D.         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39095
Contact: Carolyn Bigelow, MD    601-984-5615    cbigelow@medicine.umsmed.edu   
Contact: Dana Delaski, RN    601-815-9814    ddelaski@medicine.umsmed.edu   
Principal Investigator: Carolyn Bigelow, MD         
United States, Missouri
Children's Mercy Hospitals and Clinics Recruiting
Kansas City, Missouri, United States, 64108
Contact: Jignesh Dalal, MD    816-234-3265    jdddalal@cmh.edu   
Contact: Robin Ryan    816-855-1700    rryan@cmh.edu   
Principal Investigator: Jignesh Dalal, MD         
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Shalini Shenoy, MD    314-454-6018    shenoy@wustl.edu   
Contact: Lisa Murray    314-454-4240    murray_L@kids.wustl.edu   
Principal Investigator: Shalini Shenoy, MD         
United States, New Jersey
John Theurer Cancer Center - Hackensack University Medcial Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Scott Rowley, MD    201-996-5900    srowley@humed.com   
Contact: Marie Del Favero       mdelfavero@humed.com   
Principal Investigator: Scott Rowley, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Theresa Hahn, M.D.    716-845-5819    theresa.hahn@roswellpark.org   
Contact: Sue Flavin    716-845-3860    susan.flavin@roswellpark.org   
Principal Investigator: Theresa Hahn, PhD         
North Shore University Hospital Recruiting
Lake Success, New York, United States, 11042
Contact: Ruthee-Lu Bayer, MD    516-734-8974    rbayer@nshs.edu   
Contact: Diane Gissinger    516-734-8980    dgissing@nshs.edu   
Principal Investigator: Ruthee-Lu Bayer, MD         
Cohen Children's Medical Center of NY Recruiting
New Hyde Park, New York, United States, 11040
Contact: Indira Sahdev, M.D.    718-470-3611    isahdev@nshs.edu   
Contact: Nan Werther, RN, MS    718-470-3620    nwerther@nshs.edu   
Principal Investigator: Indira Sahdev, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Ann Jakubowski, MD    212-639-5013    jakubowa@mskcc.org   
Contact: Sarah Rivas    646-888-1025    rivass@mskcc.org   
Principal Investigator: Ann Jakubowski, MD         
Mt. Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Jacyln Davis, MD    212-241-7022    jaclyn.davis@exchange.mssm.edu   
Contact: Venesha White       venesha.white@mssm.edu   
Principal Investigator: Jaclyn Davis, M.D.         
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Jane Liesveld, MD    585-275-4099    jane_liesveld@urmc.rochester.edu   
Contact: Diane Nichols    585-273-4899    diane_nichols@urmc.rochester.edu   
Principal Investigator: Jane Liesveld, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kimberly Kasow, D.O.    919-843-2072    kimberly_kasow@med.unc.edu   
Contact: James Bradley, MA, CCRP    919-966-0987    james_bradley@med.unc.edu   
Principal Investigator: Kimberly Kasow, D.O.         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Vinod Prasad, M.D.    919-668-1100    vinod.prasad@duke.edu   
Contact: Dorothy Mazzitelli    919-668-2685    dorothy.mazzitelli@duke.edu   
Principal Investigator: Vinod Prasad, M.D.         
Wake Forest University Baptist Medical Center Recruiting
Winston Salem, North Carolina, United States, 27157-1082
Contact: Richard McQuellon, PhD    336-716-7980    rmcquell@wfubmc.edu   
Contact: Cassie Campbell, MA    336-716-2394    cascampb@wfubmc.edu   
Principal Investigator: Richard McQuellon, PhD         
United States, Ohio
Jewish Hospital Recruiting
Cincinnati, Ohio, United States, 45236
Contact: E. Randolph Broun, MD    513-686-5482    edward.broun@healthall.com   
Contact: Susan Colding, RN    513-686-3421    susan.colding@healthall.com   
Principal Investigator: E. Randolph Broun, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Brian Bolwell, MD    216-444-6922    bolwelb@ccf.org   
Contact: Shawnda Tench    216-445-5176    sungres@ccf.org   
Principal Investigator: Brian Bolwell, MD         
University Hospitals of Cleveland/Case Western Recruiting
Cleveland, Ohio, United States, 44106
Contact: Hillard Lazarus, MD    216-844-3629    hillard.lazarus@case.edu   
Contact: Thelma Vawters    216-844-8146    thelma.vawters@uhhospitals.org   
Principal Investigator: Hillard Lazarus, MD         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: George Selby, M.D.    405-271-4022    george-selby@ouhsc.edu   
Contact: Nancy Kohrt, RN    405-271-6369    nancy-kohrt@ouhsc.edu   
Principal Investigator: George Selby, M.D.         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Brandon Hayes-Lattin, MD    503-494-1551    hayeslat@ohsu.edu   
Contact: Rachel Frires       frires@ohsu.edu   
Principal Investigator: Brandon Hayes-Lattin, MD         
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Witold Rybka, MD    717-531-5059    wrybka@psu.edu   
Contact: Michelle Carraher    717-531-5647    mcarraher@hmc.psu.edu   
Principal Investigator: Witold Rybka, MD         
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nancy Bunin, M.D.    215-590-2255    buninn@email.chop.edu   
Contact: Margie Tartaglione    215-590-4029    tartaglione@email.chop.edu   
Principal Investigator: Nancy Bunin, M.D.         
United States, South Dakota
Avera Cancer Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Vinod Parameswaran, MD    605-322-3035    Vinod.Parameswaran@avera.org   
Contact: Michaela Bertram       michaela.bertram@avera.org   
Principal Investigator: Vinod Parameswaran, MD         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Madhuri Vusirikala, M.D.    214-648-7417    madhuri.vusirikala@utsouthwestern.edu   
Contact: Tracee Rainey, RN    214-648-5102    tracee.rainey@utsouthwestern.edu   
Principal Investigator: Madhuri Vusirikala, M.D.         
Texas Institute of Medicine and Surgery Recruiting
San Antonio, Texas, United States, 78229
Contact: Carlos Bachier, M.D.    210-575-6904    carlos.bachier@mhshealth.com   
Contact: Candace Taylor       Candace.taylor@mhshealth.com   
Principal Investigator: Carlos Bachier, M.D.         
United States, Utah
University of Utah, Primary Children's Medical Center Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Michael A Pulsipher, M.D.    801-662-4732    michael.pulsipher@hsc.utah.edu   
Contact: Robyn Moore    801-583-3497    robyn.moore@hsc.utah.edu   
Principal Investigator: Michael A Pulsipher, M.D.         
University of Utah Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Michael Pulsipher, M.D.    801-662-4732    michael.pulsipher@hsc.utah.edu   
Contact: Gretchen Faulk       gretchen.faulk@hci.utah.edu   
Principal Investigator: Michael Pulsipher, M.D.         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: John McCarty, M.D.    804-828-4596    jmccarty@vcu.edu   
Contact: Kathy Candler    804-828-4732    kcandler@vcu.edu   
Principal Investigator: John McCarty, M.D.         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Michael Linenberger, M.D.    206-288-2038    linen@u.washington.edu   
Contact: Debby Bernard    206-667-4458    dlbernar@fhcrc.org   
Principal Investigator: Michael Linenberger, M.D.         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Walter Longo, MD    608-265-8690    wll@medicine.wisc.edu   
Contact: Kris McDonald       kmcdonald@medicine.wisc.edu   
Principal Investigator: Walter Longo, MD         
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Parameswaran Hari, MD    414-805-4613    phari@mcw.edu   
Contact: Leigh Ann Laczkowski    414-805-8378    llaczkow@mcw.edu   
Principal Investigator: Parameswaran Hari, MD         
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
University of Utah
University of Pittsburgh
Investigators
Principal Investigator: Michael A Pulsipher, M.D. University of Utah
  More Information

No publications provided

Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT00948636     History of Changes
Other Study ID Numbers: 06-DON
Study First Received: July 28, 2009
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014