Retrospective Study of Viral Reactivation Across All Bone Marrow Transplant Protocols Since 2010
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 730
- 试验地点
- 1
- 主要终点
- To determine the incidence and risk factors for various viral complications by HSCT platform and its relation to immune reconstitution.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 4 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ELIGIBILITY CRITERIA:
- •Subjects will not be recruited for this study.
排除标准
- 未提供
研究组 & 干预措施
1
Retrospective chart review of patients who have underwent hematopoietic stem cell transplantation (HSCT)
结局指标
主要结局
To determine the incidence and risk factors for various viral complications by HSCT platform and its relation to immune reconstitution.
时间窗: 1 year
Incidence and risk factors for various viral complications by HSCT platform and its relation to immune reconstitution.
次要结局
- incidence of late CMV, EBV, BK cystitis, adenovirus, HHV6 encephalitis, JC virus, and CNS disease(1 year)
- evaluate relationship between viral infection and immunologic parameters(1 year)
- Evaluate the relationship between EBV and CMV in blood(1 year)
- evaluate relationship between GVHD and viral infection incidence/burden(1 year)
- determine overall survival and incidence of infection-related mortality(1 year)