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临床试验/NCT02560857
NCT02560857已完成不适用

Clinical Evaluation of Quantiferon-Monitor to Predict Outcomes in Solid Organ Transplant Recipients

Deepali Kumar1 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Deepali Kumar
入组人数
151
试验地点
1
主要终点
Number of participants that develop Opportunistic infections

研究概览

简要总结

The study will prospectively determine the clinical utility of non-pathogen specific cellular immunity assessment using the Quantiferon-Monitor to quantify the degree of immunosuppression. The investigators will use the results of the assay to predict whether patients develop opportunistic infections and predict organ rejection.

详细描述

Solid organ transplant (SOT) recipients undergo life-long immunosuppression to prevent allograft rejection. However, this also puts patients at significant risk for opportunistic infection. The degree of immunosuppression varies for each individual and is likely influenced by a combination of clinical factors such as antirejection medication, comorbidities, patient age as well as the state of patient immune system. Thus far, there have been no standardized methods to quantify the degree of global immunosuppression. A new blood test (Quantiferon-Monitor) has been recently developed that might help predict the level of immune suppression. The purpose of this study is to determine whether this new test will help determine a person's level of immune suppression after organ transplant. This will be done by trying to relate the level of immunity with the development of infection or rejection. If the test for immunosuppression is helpful, it may help us to better take into account the differences in patients when designing therapy. Ultimately, it may help develop better ways for preventing infections and transplant rejections.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult SOT recipients on at least one immunosuppressive medication able to comply with the protocol.

排除标准

  • 未提供

结局指标

主要结局

Number of participants that develop Opportunistic infections

时间窗: 1 year

The results of the assay will be used to predict whether patients develop opportunistic infections.

次要结局

  • Number of participants that develop Acute cellular rejection(1 year)

研究者

发起方
Deepali Kumar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Deepali Kumar

Physician, Transplant Infectious Diseases

University Health Network, Toronto

研究点 (1)

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