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Long Term Effects On Recipients of Hematopoietic Stem Cell Transplantation

Longitudinal Evaluation of Recipients of Hematopoietic Stem Cell Transplantation (HSCT)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01629017
Enrollment
800
Registered
2012-06-27
Start date
1995-01-31
Completion date
2099-01-31
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood and Marrow Transplant (BMT)

Brief summary

This project allows for the systematic collection and analysis of long-term follow-up clinical parameters in children who have received a stem cell transplant. The data collected will assist in determining appropriate intervention and treatment plans for patients enrolled on this study. In addition, future patients may benefit by having the ability to anticipate problems and develop methods of prevention or early intervention.

Detailed description

Primary Objective: Implement long-term follow-up guidelines for children, adolescents and young adults who are survivors of HSCT while establishing a database which captures the survivor's lifetime care. Secondary Objectives: * Collect evidence-based data through a structured framework of periodic physical examination, laboratory and medical tests to monitor late effects in our HSCT survivors. * Establish standards of care for late effects of therapy post HSCT for malignant and non-malignant diagnoses. * Provide early identification and intervention towards recognized problems, as well as consistent education to foster a healthy lifestyle to all survivors. * Collect blood and tissue samples to study immune reconstitution of all immune cell types and learn more about immune reconstitution and its affect on post-HSCT complications and disease free survival.

Interventions

None listed

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

* Participant is scheduled to receive OR has received a hematopoietic stem cell transplant (HSCT) for any condition. * Participant may have had a HSCT in another institution than Lucile Packard Children's Hospital (LPCH) yet has transferred follow-up long-term care to our institution and is being seen through the late-effects clinic from the Pediatric HSCT program. * Participant AND/OR parent/legally authorized representative is able to provide written informed consent and assent (as applicable) for participation.

Exclusion criteria

* Participant has relapsed from a malignant diagnosis post HSCT and is not being worked-up for a new HSCT. * Participant or patient's authorized guardian is unable to provide consent and assent

Design outcomes

Primary

MeasureTime frame
Collection of data and tissue samples with the goal of establishing a systematic follow-up care for HSCT recipients and a comprehensive database which can capture the particularities of survivors' clinical status through their life span.This research study is expected to continue as long as we continue to perform clinical trials for children with diseases that involve the bone marrow or are affected by bone marrow production.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026