Prediction of Hepatitis C Recurrence in Liver Transplant Recipients
研究概览
详细说明
To establish whether in-vitro donor-specific immune reactivity patterns can differentiate between those liver transplant recipients who are positive for the Hepatitis C virus (HCV) who are at high risk and those who are at low risk for graft loss secondary to early recurrence of HCV.
An assessment of the recipient's donor-specific immune status can be achieved by measuring T-cell activity, specifically alloreactive primed (donor-specific) T cell activity. It has been shown that detection of IFN-y in short-term enzyme-linked-immunosorbent-spot (ELISPOT) assay is consistent with the presence of primed memory T cells (6). In the transplantation setting, T cells of an allograft recipient that secret IFN-y after short in-vitro exposure to donor cells represent a prior sensitization of recipient to donor antigens in vivo. Clinically interpreted - this priming event may signify the presence of an up-coming, or an on-going, rejection episode. Our limited preliminary data suggest an additional potential clinical value for the in-vitro assessment of donor-specific IFN-y production in predicting those liver transplant recipients at higher risk for recurrence of Hepatitis C.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern Memorial Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients must be >18 years of age
- Chronic HCV infection (and cirrhosis) - group 1
- HCV RNA positive pre-transplant - group 1
- Liver cirrhosis not due to HCV infection - group 2
Exclusion Criteria:
- All patients < than 18 years of age
- Patients with hepatitis C infection
- Candidates receiving multi-organ combined transplantation
- Patients who have received a previous liver transplantation
- Patients who are unable to understand English
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Group 1: HCV Positive
50 patients whom are HCV positive
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Group 2: HCV Negative
50 patients whom are HCV negative.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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To assess whether in-vitro donor-specific immune reactivity patterns are indicative of rate of HCV recurrence
大体时间:Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18
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Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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To compare in-vitro donor-specific immune reactivity patterns and rejection episodes in liver transplant recipients
大体时间:Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18
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Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18
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To establish immune monitoring protocol for HCV+ liver transplant recipients that will aid in tailoring immunosuppression protocols for these patients and in devising strategies to treat patients with recurrent hepatitis C post-liver transplantation.
大体时间:Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18
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Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18
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合作者和调查者
调查人员
- 首席研究员:Talia Baker, MD、Northwestern Memorial Hospital
- 首席研究员:Anat Tambur, MD, PhD、Northwestern University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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