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

NCT ID: NCT00674882

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

637 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-07

Study Completion Date

2022-10-03

Brief Summary

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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

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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

Conditions

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Hematopoietic Stem Cell Transplantation

Keywords

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Hematopoietic stem cell transplant Follow-up studies Outcomes research Data collection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Participants

Data Collection

Data Collection

Intervention Type OTHER

Data Collection, Outcomes Research, Statistical Data Analysis, Longitudinal Study

Interventions

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Data Collection

Data Collection, Outcomes Research, Statistical Data Analysis, Longitudinal Study

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brandon Triplett, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

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NCI-2021-10847

Identifier Type: REGISTRY

Identifier Source: secondary_id

BMTFU

Identifier Type: -

Identifier Source: org_study_id