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

Completed

• Conditions: Hematopoietic Stem Cell Transplantation
• Interventions: Other: Data Collection

• Registration Number: NCT00674882
• Lead Sponsor: St. Jude Children's Research Hospital

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.

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 Timeline

• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-08
• Study Start: 2019-11-07
• Primary Completion: 2020-03-12
• Study Completion: 2022-10-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 637

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

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	Data Collection	Data Collection

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States