Retrospective Study of Viral Reactivation Across All Bone Marrow Transplant Protocols Since 2010
Condition: Viral Infections
MeSH terms: Infections; Virus Diseases
Study type: Observational

Summary: 
      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: 
      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.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This protocol is a retrospective chart review of patients who have underwent hematopoietic
        stem cell transplantation (HSCT) at the NIH Clinical Center
      
Keywords: Reactivation or Proliferation of Latent Viral Infections.; Viral Infection; Lymphoproliferation; Natural History