Correlation of Molecular Biomarkers With Biopsy Findings and Outcomes in Renal Transplant Recipients
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
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California
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Sacramento、California、美国、95817
- University of California, Davis Transplant Center
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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 who meet all of the following criteria are eligible for enrollment as study participants:
- Male and female recipients of all races, ≥18 years of age.
- Patients undergoing primary or subsequent deceased-donor or living donor kidney transplantation.
- Subject and/or guardian must be able to provide informed consent.
- Subject and/or guardian must be able to comply with the study protocol.
Exclusion Criteria:
- Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
- Recipients of previous non-renal solid organ and/or islet cell transplantation
- Infection with HIV.
Inability or unwillingness of a participant and/or guardian to provide informed consent
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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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Phase 1
A. OBJECTIVE: The objective of this phase of the study is to allow the clinical site to gain familiarity with patient recruitment, sample and data collection, and interpretation of the proteogenomic biomarker report provided, through retrospective analysis. This phase of the study will provide a platform for the transplant physicians to gain confidence with the format, logistics, and potential use of the biomarker tests on blood and tissue. B. STUDY DESIGN: Enroll 20 subjects who are post-transplant and are undergoing kidney transplant biopsies at the UC Davis transplant center. Ten subjects will be enrolled who are receiving surveillance "protocol biopsies" and 10 subjects. |
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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Biopsy prove acute rejection
大体时间：12 months
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Incidence of acute rejection at the time of any kidney biopsy
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Gene Expression Profiling
大体时间：12 months
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Blood and tissue collection from each subject at the time of each for cause or protocol kidney biopsy
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12 months
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合作者和调查者
调查人员
- 首席研究员：Angelo DeMattos, MD、University of California, Davis Health Systems
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
与本研究相关的术语
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.