Long Term Effects On Recipients of Hematopoietic Stem Cell Transplantation

NCT01629017 | Recruiting

• 1 other identifier: IRB-4134
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood and Marrow Transplant (BMT)

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Stanford Blood and Marrow Transplant clinic.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, saliva

Study Officials

• Ami Shah

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: June 27, 2012
• Study Start: January 1, 1995
• Primary Completion (Estimated): January 1, 2099
• Study Completion (Estimated): January 1, 2099
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)