We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 February 2017 by St. Jude Children's Research Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT00674882
First Posted: May 8, 2008
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
  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
Study Design: Observational Model: Other
Time Perspective: Other
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 ]

Estimated Enrollment: 600
Actual Study Start Date: January 16, 2002
Estimated Study Completion Date: December 31, 2045
Estimated Primary Completion Date: December 31, 2040 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants
Data Collection
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674882


Contacts
Contact: Brandon Triplett, MD 866-278-5833 referralinfo@stjude.org

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

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00674882     History of Changes
Other Study ID Numbers: BMTFU
First Submitted: May 6, 2008
First Posted: May 8, 2008
Last Update Posted: April 4, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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