Protocol For Collecting Long-Term Follow-Up Data On Recipients of Bone Marrow and Blood Stem Cell Transplant

This study is currently recruiting participants.
Verified May 2013 by St. Jude Children's Research Hospital
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00674882
First received: May 6, 2008
Last updated: May 13, 2013
Last verified: May 2013

May 6, 2008
May 13, 2013
January 2002
December 2040   (final data collection date for primary outcome measure)
To provide ongoing review of long-term clinical and psychosocial outcomes and late effects of hematopoietic stem cell recipients at St. Jude Children's Research Hospital [ Time Frame: Long Term Follow Up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00674882 on ClinicalTrials.gov Archive Site
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Protocol For Collecting Long-Term Follow-Up Data On Recipients of Bone Marrow and Blood Stem Cell Transplant
Protocol For Collecting Long-Term Follow-Up Data On Recipients of Hematopoietic Stem Cell Transplant

This protocol allows for ongoing data collection to assess the long-term clinical and psychosocial outcomes of pediatric patients who have received a hematopoietic stem cell transplant at St. Jude Children's Research Hospital.

The purpose of this protocol is to provide ongoing data collection and review of long-term outcome and late effects in a large cohort of St. Jude Children's Research Hospital autologous and allogeneic hematopoietic stem cell recipients. Central coordination of clinical and psychosocial late effects monitoring and reporting can facilitate timely communication about life-threatening or unanticipated clinical outcomes as well as significant psychological, social and behavioral sequelae effects on the recipient and their family members. The resultant data may enable researchers in their development of current clinical and psychosocial studies, as well as monitoring predisposed survivors who may benefit from preventive or corrective interventions. Physicians and researchers may be able to learn how to identify these problems earlier, to take better care of these problems, or to implement preventive measures for future transplant recipients

Observational
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Probability Sample

St. Jude patient at least one year post receipt of and autologous or allogeneic transplant for a malignant or non-malignant condition

Hematopoietic Stem Cell Transplantation
Other: Data Collection
Data Collection, Outcomes Research, Statistical Data Analysis, Longitudinal Study
1
Intervention: Other: Data Collection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
December 2045
December 2040   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • St. Jude patients actively monitored in the BMT-AFU clinic after receiving HSC transplant for a malignant or non-malignant condition.
  • St. Jude alumnus who has received a hematopoietic stem cell transplant for a malignant or non-malignant condition and is monitored by the Tumor Registry

Exclusion Criteria:

  • St. Jude consult patients who received hematopoietic stem cell transplantation at other institutions.
  • Patient who had received a gene-transduced product
  • St. Jude patients permanently discharged from care and follow-up.
Both
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No
Contact: Christine Hartford, MD 866-278-5833 info@stjude.org
United States
 
NCT00674882
BMTFU
No
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
Not Provided
Principal Investigator: Christine Hartford, MD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP