Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Bone Marrow Transplant Recipients (ACE-BMT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- CMV infection
研究概览
简要总结
CMV is one of the most important opportunistic infection in transplant recipients. In South Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity for CMV IgG before bone marrow organ transplantation is a laboratory test of choice to stratify the risk of CMV reactivation after solid organ transplantation. Theoretically, CMV-specific cell-mediate immune response before and after bone marrow transplantation will further categorize the patients into high or low risk of CMV development after bone marrow transplantation. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in bone marrow transplant candidates to predict the development of CMV infection after transplantation.
详细描述
We will evaluate whether CMV-specific cell-mediated immune response before transplant, 1 month, 3 months, and 6 months after transplantation will predict CMV infection after bone marrow transplantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 16 or more
- •agree with written informed consent
排除标准
- •no exclusion criteria
结局指标
主要结局
CMV infection
时间窗: 6 months after transplantation
CMV infection is defined as follows. 1. CMV viremia: CMV antigenemia or CMV quantitative PCR (+) 2. CMV disease: CMV syndrome or tissue-invasive CMV disease i) CMV syndrome: ① CMV viremia ② temperature \> 38 without other cause ③ WBC \< 4000, atypical lymphocyte \> 3%, transaminase elevation, platelet \< 100,000/mm ii) tissue-invasive CMV disease: evidence of CMV in histopathologic specimen (inclusion body or viral antigen in biopsy or bronchoalveolar lavage fluid)
次要结局
- mortality(6 months after transplantation)
研究者
Sung-Han Kim
Assocaite Professor
Asan Medical Center