Retrospective Study of Viral Reactivation Across All Bone Marrow Transplant Protocols Since 2010
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Background: Some blood and immune disorders can be helped with HSCT. This is allogeneic hematopoietic stem cell transplantation. The person who gets the stem cells has their immune system suppressed. This is done to help prevent their body from rejecting the transplant. During this time, the person is at a high risk to get viral infections. Researchers want to study the records of people who had transplants a few years ago. They want to look at how often certain viral complications happened. Objective: To study how often certain viral complications occurred after HSCT and what risks factors were involved. Eligibility: Records will be reviewed. No participants will be contacted. Design: Researchers will review medical records from the NIH Clinical Center. The records will be from people who had HSCT between 2010 and 2015 when they were between 4 and 85 years old. They already gave consent for their data to be studied. Data collected will include: Vital statistics like age and sex Viral status of the recipient and donor Reason for transplant Transplant details How the immune system recovered after transplant If the recipient got graft versus host disease Any infections Overall survival
- - ELIGIBILITY CRITERIA: Subjects will not be recruited for this study.
Locations & Contacts
Status: Enrolling by invitation
Contact: National Cancer Institute Referral Office
Trial Objectives and Outline
This protocol is a retrospective chart review of patients who have underwent hematopoietic stem cell transplantation (HSCT) at the NIH Clinical Center. If this proposal is approved, BTRIS will identify and populate the patients in these protocols, and BTRIS identified reports will be used going forward. BTRIS identified reports will be used to review patient progress notes, all aspects of the transplant platform, as well as viral titers over the course of each patient s follow-up, supplemented by review of paper or CRIS electronic medical records as needed. The study will involve review of patient records and will not use specimens or participant contact. The participants whose records will be reviewed in this protocol were enrolled in NIH protocols between 2010 and June 1, 2018. BTRIS policy requires approval from Principal Investigators on certain protocols. These Principal Investigators have been contacted via email for permission to conduct this study and have verified that none of the original protocols or informed consent documents precludes such a review of clinical data.
Trial Phase & Type
No phase specified
Not provided by clinicaltrials.gov
National Cancer Institute
Jennifer Ann Kanakry
Secondary IDs 17-C-N079, NCI-2018-03455, 17-C-N079, NCI-2017-00612
Clinicaltrials.gov ID NCT03111745