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

December 17, 2024 updated by: St. Jude Children's Research Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

637

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants
Data Collection
Other: Data Collection
Data Collection, Outcomes Research, Statistical Data Analysis, Longitudinal Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Long Term Follow Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2019

Primary Completion (Actual)

March 12, 2020

Study Completion (Actual)

October 3, 2022

Study Registration Dates

First Submitted

May 6, 2008

First Submitted That Met QC Criteria

May 7, 2008

First Posted (Estimated)

May 8, 2008

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BMTFU
  • NCI-2021-10847 (Registry Identifier: NCI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe