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Recruiting

NCT Number: NCT01629017

Long Term Effects On Recipients of Hematopoietic Stem Cell Transplantation

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.

Recruiting

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Ami Shah

PRINCIPAL_INVESTIGATOR

Cancer Clinical Trials Office

CONTACT

(650) 498-7061

Nivedita A Kunte

CONTACT

[email protected]

650-497-2038

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
1995
Primary completion
2099
Study completion
2099
First posted
Jun 27, 2012
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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