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Completed

NCT Number: NCT03111745

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

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

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Key information

Conditions

Viral Infections Infections Virus Diseases

Age range

4 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • ELIGIBILITY CRITERIA:

Subjects will not be recruited for this study.

Treatment and study plan

Primary outcomes

  1. To determine the incidence and risk factors for various viral complications by HSCT platform and its relation to immune reconstitution.

    Time frame: 1 year

    Incidence and risk factors for various viral complications by HSCT platform and its relation to immune reconstitution.

Secondary outcomes

  1. incidence of late CMV, EBV, BK cystitis, adenovirus, HHV6 encephalitis, JC virus, and CNS disease

    Time frame: 1 year

    incidence of late CMV, EBV, BK cystitis, adenovirus, HHV6 encephalitis, JC virus, and CNS disease

  2. Evaluate the relationship between EBV and CMV in blood

    Time frame: 1 year

    Evaluate the relationship between EBV and CMV in blood

  3. evaluate relationship between viral infection and immunologic parameters

    Time frame: 1 year

    evaluate relationship between viral infection and immunologic parameters

  4. evaluate relationship between GVHD and viral infection incidence/burden

    Time frame: 1 year

    evaluate relationship between GVHD and viral infection incidence/burden

  5. determine overall survival and incidence of infection-related mortality

    Time frame: 1 year

    determine overall survival and incidence of infection-related mortality

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Apr 13, 2017
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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