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

May 7, 2026 updated by: National Cancer Institute (NCI)

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

730

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute (NCI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

  • ELIGIBILITY CRITERIA:

Subjects will not be recruited for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
1
Retrospective chart review of patients who have underwent hematopoietic stem cell transplantation (HSCT)

What is the study measuring?

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.
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
Evaluate the relationship between EBV and CMV in blood
1 year
evaluate relationship between viral infection and immunologic parameters
Time Frame: 1 year
evaluate relationship between viral infection and immunologic parameters
1 year
evaluate relationship between GVHD and viral infection incidence/burden
Time Frame: 1 year
evaluate relationship between GVHD and viral infection incidence/burden
1 year
determine overall survival and incidence of infection-related mortality
Time Frame: 1 year
determine overall survival and incidence of infection-related mortality
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Dimana Dimitrova, M.D., National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2017

Primary Completion (Actual)

December 29, 2018

Study Completion (Actual)

February 18, 2020

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 6, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999917079
  • 17-C-N079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD recorded in the medical record will be shared with intramural investigators upon request.

IPD Sharing Time Frame

Clinical data available during the study and indefinitely.

IPD Sharing Access Criteria

Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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