Retrospective Study of Viral Reactivation Across All Bone Marrow Transplant Protocols Since 2010
NCT ID: NCT03111745
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
730 participants
OBSERVATIONAL
2017-04-13
2020-02-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Retrospective chart review of patients who have underwent hematopoietic stem cell transplantation (HSCT)
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Subjects will not be recruited for this study.
4 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dimana Dimitrova, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Cancer Institute (NCI)
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Tischer J, Engel N, Fritsch S, Prevalsek D, Hubmann M, Schulz C, Zoellner AK, Bucklein V, Reibke R, Mumm F, Rieger CT, Hill W, Ledderose G, Stemmler HJ, Kohnke T, Jager G, Kolb HJ, Schmid C, Moosmann A, Hausmann A. Virus infection in HLA-haploidentical hematopoietic stem cell transplantation: incidence in the context of immune recovery in two different transplantation settings. Ann Hematol. 2015 Oct;94(10):1677-88. doi: 10.1007/s00277-015-2423-y. Epub 2015 Jun 10.
Kang E, Gennery A. Hematopoietic stem cell transplantation for primary immunodeficiencies. Hematol Oncol Clin North Am. 2014 Dec;28(6):1157-70. doi: 10.1016/j.hoc.2014.08.006. Epub 2014 Sep 16.
Reddehase MJ. Mutual Interference between Cytomegalovirus and Reconstitution of Protective Immunity after Hematopoietic Cell Transplantation. Front Immunol. 2016 Aug 4;7:294. doi: 10.3389/fimmu.2016.00294. eCollection 2016.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17-C-N079
Identifier Type: -
Identifier Source: secondary_id
999917079
Identifier Type: -
Identifier Source: org_study_id