Long Term Effects On Recipients of Hematopoietic Stem Cell Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01629017
First received: June 25, 2012
Last updated: October 11, 2013
Last verified: October 2013
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Leigh Shinn    650-724-9179    leighs@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
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: October 11, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014