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. Identifier: NCT01629017
Recruitment Status : Recruiting
First Posted : June 27, 2012
Last Update Posted : November 1, 2016
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University

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)

Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Long Term Effects On Recipients of Hematopoietic Stem Cell Transplantation
Study Start Date : January 1995
Estimated Primary Completion Date : January 2099
Estimated Study Completion Date : January 2099

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

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.

Inclusion Criteria:

  1. Children up to 18 years old at the time of enrollment.
  2. Status post stem cell transplantation after hospital discharge from transplant.
  3. Confirmation for participation through check marks on the written informed consent from the subject (as applicable) AND/OR participant's parent/legally authorized representative prior using data for research purposes

Exclusion Criteria:

  1. Patient height is < 132 cm.
  2. Patient is currently using oxygen therapy or has resting oxygen saturation (SaO2) < 90%.
  3. Patient is unable to walk without the aid of devices or support.

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 identifier (NCT number): NCT01629017

United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Leigh Shinn    650-724-9179   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Rajni Agarwal-Hashmi         
Sub-Investigator: Sharon Elizabeth Williams         
Sub-Investigator: Kenneth Weinberg         
Sub-Investigator: Christopher C Dvorak         
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Principal Investigator: Rajni Agarwal-Hashmi Stanford University

Responsible Party: Stanford University Identifier: NCT01629017     History of Changes
Other Study ID Numbers: PEDSBMT179
4134 ( Other Identifier: Stanford IRB )
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016