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Long Term Effects On Recipients of Hematopoietic Stem Cell Transplantation

This study is currently recruiting participants.
Verified February 2013 by Stanford University
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01629017
First received: June 25, 2012
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Blood and Marrow Transplant (BMT)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Long Term Effects On Recipients of Hematopoietic Stem Cell Transplantation

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood, saliva


Estimated Enrollment: 800
Study Start Date: January 1995
Estimated Study Completion Date: January 2099
Estimated Primary Completion Date: January 2099 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Stanford Blood and Marrow Transplant clinic.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629017

Contacts
Contact: Laila Craveiro (650) 724-9179 craveiro@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Laila Craveiro     650-724-9179     craveiro@stanford.edu    
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)
Investigators
Principal Investigator: Rajni Agarwal-Hashmi Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01629017     History of Changes
Other Study ID Numbers: PEDSBMT179, 96823, 4134
Study First Received: June 25, 2012
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 22, 2013