预测巨细胞病毒 (CMV) (PREDICT CMV)
预测肺移植后患者风险的前瞻性多中心巨细胞病毒 (CMV) 特异性免疫监测 (CTOT-22)
The overall objective of this study is to establish a personalized test to measure individualized cytomegalovirus (CMV) specific immunity in lung transplant recipients in an effort to guide antiviral prophylaxis duration in clinical practice.
Targeted participants are those:
- enrolled in clinical research study CTOT-20 (Clinical Trials.gov ID: NCT02631720) who
- are CMV recipient positive by serology as determined using methods in accordance with current local organ procurement organization policies.
研究概览
详细说明
Cytomegalovirus (CMV) is a common virus. The virus is spread from one person to another through infected body fluids. In those with a normal immune system, CMV does not cause much of a problem. The immune system keeps the virus under control so most people do not have any symptoms. Once infected, the virus usually stays dormant (inactive) in the body for a person's entire life. This means some of the cells in the body are infected and the virus can become active again.
Lung transplant recipients take anti-rejection medicines to prevent the body from rejecting the transplanted lung(s). Although anti-rejection medications help protect the transplanted lung(s) from the body's immune system, these medications also decrease the body's ability to fight infections. This reduces the immune system's ability to control viruses like CMV. Many transplant recipients take an antiviral medication early after transplant to help the body control the CMV virus. This is the time that risk of infection would be highest. Sometimes recipients get an active CMV infection after stopping these medicines. If this happens, the infection is treated and monitored.
In this study, investigators are trying to determine whether a blood test can predict development of active CMV infection in lung transplant recipients. Specifically, the clinical research study will prospectively assess the performance of an immune signature based on the "ex vivo" measurement of T cell CMV specific immunity in predicting freedom from future CMV infections among recipient positive (R+) lung transplant participants receiving standard durations of valganciclovir prophylaxis.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Toronto、加拿大、M5G 2C4
- Toronto General Hospital: Transplantation
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Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins Hospital: Transplantation
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center: Transplantation
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic Foundation: Transplantation
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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
Adult lung transplant recipients undergoing lung transplant at one of the four participating centers and concurrently enrolled in CTOT-20 (Clinical Trials.gov ID: NCT02631720).
描述
Inclusion Criteria:
Individuals who meet all of the following criteria are eligible for enrollment as study participants:
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Must be able to understand and provide written informed consent;
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Anticipated listing for lung transplantation OR listed for lung transplant OR is within 45 days of having received a single or bilateral cadaveric donor lung transplant;
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Undergoing first lung transplant operation;
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Transplant surgery to be performed or performed at enrolling center;
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Concurrent participation in CTOT-20 (Clinical Trials.gov ID: NCT02631720); and
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CMV-seropositive lung transplant recipient, using methods in accordance with current local organ procurement organization policies.
- Note: Concurrent participation in immune monitoring studies or interventional device trials are permitted.
Exclusion Criteria:
Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
- Unwilling to enroll in CTOT-20 (Clinical Trials.gov ID: NCT02631720);
- Multi-organ recipient;
- Prior recipient of any solid organ transplant, including prior lung transplant;
- Prior or concurrent recipient of bone marrow transplant;
- Human Immunodeficiency Virus (HIV) infection;
- Pregnant or planned pregnancy;
- Any condition that, in the investigator's opinion, would make it unlikely for the recipient to complete follow up procedures or complete the study; or
- Participation in an investigational drug trial at the time of enrollment visit.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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CMV+ First Lung Transplant Recipients
Participants enrolled in one of four North American sites in clinical research study CTOT-20 (Clinical Trials.gov ID: NCT02631720) who are cytomegalovirus positive by serology (e.g., CMV Recipient positive). |
Serial blood draws. Participants will be enrolled either pre-transplant or within 45 days post-transplant and will be followed over the course of 18 months post transplant. Protocol mandated serial measurement of cytomegalovirus (CMV)-specific immune signature will occur pre-transplant (as applicable) and at post-transplant timepoint months 2, -3, -6, -9, -12 and -18.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease within 6 months Post CMV Prophylaxis Discontinuation
大体时间：From CMV Prophylaxis Discontinuation to 6 Months Post CMV Prophylaxis Discontinuation
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Participants will be evaluated for CMV infection or disease according to each center's standard of care clinical protocol. All centers have aligned their clinical practice to include, at a minimum, a CMV infection and a CMV disease assessment at the time of prophylaxis discontinuation, monthly for the first 6 months after discontinuation, and quarterly after that up to 18 months post transplantation. |
From CMV Prophylaxis Discontinuation to 6 Months Post CMV Prophylaxis Discontinuation
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Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease Within 18 Months Post-Transplant
大体时间：From CMV Prophylaxis Discontinuation to 18-Months Post-Transplant
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Participants will be evaluated for CMV infection or disease according to each center's standard of care clinical protocol. All centers have aligned their clinical practice to include, at a minimum, a CMV infection and a CMV disease assessment at the time of prophylaxis discontinuation, monthly for the first 6 months after discontinuation, and quarterly after that up to 18 months post transplantation. |
From CMV Prophylaxis Discontinuation to 18-Months Post-Transplant
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合作者和调查者
调查人员
- 学习椅：Laurie Snyder, MD, MHS、Duke University Medical Center: Transplantation
- 学习椅：Scott Palmer, MD, MHS、Duke University Medical Center: Transplantation
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 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.