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 November 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: November 11, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Hematopoietic Stem Cell Transplantation
Other: Data Collection

Study Type: Observational
Official Title: Protocol For Collecting Long-Term Follow-Up Data On Recipients of Hematopoietic Stem Cell Transplant

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
Study Start Date: January 2002
Estimated Study Completion Date: December 2045
Estimated Primary Completion Date: December 2040 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: Data Collection
Data Collection, Outcomes Research, Statistical Data Analysis, Longitudinal Study

Detailed Description:

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

  Eligibility

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

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00674882

Contacts
Contact: Christine Hartford, MD 866-278-5833 info@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Christine Hartford, MD    866-278-5833    info@stjude.org   
Principal Investigator: Christine Hartford, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Christine Hartford, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00674882     History of Changes
Other Study ID Numbers: BMTFU
Study First Received: May 6, 2008
Last Updated: November 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Hematopoietic stem cell transplant
Follow-up studies
Outcomes research
Data collection

ClinicalTrials.gov processed this record on April 23, 2014