Retrospective Study of Viral Reactivation Across All Bone Marrow Transplant Protocols Since 2010
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 4 - 85 |
| Updated: | 4/6/2019 |
| Start Date: | April 10, 2019 |
| End Date: | March 19, 2020 |
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
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
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 June 1, 2018. 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.
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 June 1, 2018. 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.
- ELIGIBILITY CRITERIA:
Subjects will not be recruited for this study.
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National Cancer Institute (NCI) The National Cancer Institute (NCI) is part of the National Institutes...
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