Retrospective Study of Viral Reactivation Across All Bone Marrow Transplant Protocols Since 2010

Study Overview
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Brief Summary
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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

Detailed Description
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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 December 1, 2020. 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.

Official Title
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Retrospective Study of Viral Reactivation Across All Bone Marrow Transplant Protocols Since 2010

Conditions
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Viral Infections

Participation Criteria
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Eligibility Criteria
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ELIGIBILITY CRITERIA: Subjects will not be recruited for this study.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Retrospective chart review of patients who have underwent hematopoietic stem cell transplantation (HSCT) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the incidence and risk factors for various viral complications by HSCT platform and its relation to immune reconstitution. | Incidence and risk factors for various viral complications by HSCT platform and its relation to immune reconstitution. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of late CMV, EBV, BK cystitis, adenovirus, HHV6 encephalitis, JC virus, and CNS disease | incidence of late CMV, EBV, BK cystitis, adenovirus, HHV6 encephalitis, JC virus, and CNS disease | 1 year | 
| Evaluate the relationship between EBV and CMV in blood | Evaluate the relationship between EBV and CMV in blood | 1 year | 
| evaluate relationship between viral infection and immunologic parameters | evaluate relationship between viral infection and immunologic parameters | 1 year | 
| evaluate relationship between GVHD and viral infection incidence/burden | evaluate relationship between GVHD and viral infection incidence/burden | 1 year | 
| determine overall survival and incidence of infection-related mortality | determine overall survival and incidence of infection-related mortality | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reactivation or Proliferation of Latent Viral Infections., Viral Infection, Lymphoproliferation, Natural History