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

• Sponsor: St. Jude Children's Research Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00674882
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 525.3
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hematopoietic Stem Cell Transplantation	Other: Data Collection

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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Protocol For Collecting Long-Term Follow-Up Data On Recipients of Hematopoietic Stem Cell Transplant
• Actual Study Start Date: Feb 20, 2002
• Anticipated Primary Completion Date: Dec 1, 2040
• Anticipated Study Completion Date: Dec 1, 2045

Arms and Interventions

Arm	Intervention/Treatment
Participants Data Collection	Other: Data Collection; Data Collection, Outcomes Research, Statistical Data Analysis, Longitudinal Study

Outcome Measures

Primary Outcome Measures

1. 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 [Long Term Follow Up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	St. Jude Children's Research Hospital	Memphis	Tennessee	United States	38105

Sponsors and Collaborators

• St. Jude Children's Research Hospital

Investigators

• Principal Investigator: Brandon Triplett, MD, St. Jude Children's Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Publications

None provided.

• Responsible Party: St. Jude Children's Research Hospital
• ClinicalTrials.gov Identifier: NCT00674882
• Other Study ID Numbers: BMTFU
• First Posted: May 8, 2008
• Last Update Posted: Oct 26, 2021
• Last Verified: Oct 1, 2021

• 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

Study Results

No Results Posted as of Oct 26, 2021