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Long Term Effects On Recipients of Hematopoietic Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01629017
Recruitment Status : Recruiting
First Posted : June 27, 2012
Last Update Posted : September 10, 2022
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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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.

Condition or disease
Blood and Marrow Transplant (BMT)

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Longitudinal Evaluation of Recipients of Hematopoietic Stem Cell Transplantation (HSCT)
Study Start Date : January 1995
Estimated Primary Completion Date : January 2099
Estimated Study Completion Date : January 2099
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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. ]

Biospecimen Retention:   Samples With DNA
blood, saliva

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stanford Blood and Marrow Transplant clinic.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629017


Locations
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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Nivedita A Kunte    650-497-2038    nkunte@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Ami Shah         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Ami Shah Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01629017    
Other Study ID Numbers: IRB-4134
96823
4134 ( Other Identifier: Stanford IRB )
PEDSBMT179 ( Other Identifier: OnCore )
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: September 10, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No