Long Term Effects On Recipients of Hematopoietic Stem Cell Transplantation
This study is currently recruiting participants.
Verified October 2013 by Stanford University
Information provided by (Responsible Party):
First received: June 25, 2012
Last updated: October 11, 2013
Last verified: October 2013
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.
Blood and Marrow Transplant (BMT)
||Observational Model: Case Control
Time Perspective: Prospective
||Long Term Effects On Recipients of Hematopoietic Stem Cell Transplantation
Biospecimen Retention: Samples With DNA
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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2099 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||up to 18 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Stanford Blood and Marrow Transplant clinic.
- Children up to 18 years old at the time of enrollment.
- Status post stem cell transplantation after hospital discharge from transplant.
- 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
- Patient height is < 132 cm.
- Patient is currently using oxygen therapy or has resting oxygen saturation (SaO2) < 90%.
- Patient is unable to walk without the aid of devices or support.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629017
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
|Contact: Leigh Shinn 650-724-9179 firstname.lastname@example.org |
|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 |
No publications provided
ClinicalTrials.gov processed this record on March 10, 2014
History of Changes
|Other Study ID Numbers:
||PEDSBMT179, 96823, 4134
|Study First Received:
||June 25, 2012
||October 11, 2013
||United States: Institutional Review Board