Investigation of Cisplatin-Related Kidney Toxicity
2018年9月10日 更新者：University of Chicago
Investigation of Germline Genetic Determinants and Early Biomarkers of Cisplatin-Related Nephrotoxicity
The purpose of this study is to identify novel biomarkers of kidney injury in patients receiving cisplatin.
This study will also collect DNA for future analysis.
研究概览
地位
完全的
条件
详细说明
This study will look for novel biomarkers of kidney injury in patients receiving cisplatin in patients currently receiving cisplatin.
DNA will be collected both prospectively and retrospectively (from patients that have previously received cisplatin.
研究类型
观察性的
注册 (实际的)
102
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Illinois
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Chicago、Illinois、美国、60637
- University of Chicago
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients receiving anti-cancer treatment with cisplatin (or previously treated with cisplatin) at a participating academic medical center.
描述
Prospective Analysis Group
Inclusion Criteria:
- Patients about to receive intravenous cisplatin for the first time as part of cancer chemotherapy.
- Aged 18 years and older.
- Ability to understand and willingness to sign a written consent document.
- Patients may be receiving cisplatin in combination with other chemotherapeutic agents.
- Patients may be receiving cisplatin in the context of another clinical trial.
Exclusion Criteria:
- Prior receipt of cisplatin.
- Patients on dialysis or other renal replacement therapy prior to starting cisplatin.
- Uncontrolled hypo- or hyperthyroidism (patients on chronic stable doses of thyroid replacement medication are eligible).
Retrospective Analysis Group
Inclusion Criteria:
- Patients that have previously received intravenous cisplatin as part of cancer chemotherapy.
- Aged 18 years and older.
- Ability to understand and willingness to sign a written consent document.
- Patients that received cisplatin in combination with other chemotherapeutic agents are eligible.
- Patients that received cisplatin in the context of a clinical trial are eligible.
Exclusion Criteria:
- Unable or unwilling to submit to a one-time blood draw.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Prospecitive Analysis
Patients currently receiving cisplatin as treatment for their cancer.
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Urine samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.
blood samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.
Blood sample collected for DNA analysis at anytime while on-study.
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Restrospective Analysis
Patients that have previously received cisplatin as treatment for their cancer.
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Blood sample collected for DNA analysis at anytime while on-study.
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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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Change in urine biomarker (NGAL) after cisplatin
大体时间：while on drug and up to 35 days after end of treatment
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while on drug and up to 35 days after end of treatment
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change in blood and urine cystatin C
大体时间：while on drug and up to 35 days after end of treatment
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while on drug and up to 35 days after end of treatment
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Change in blood NGAL while receiving cisplatin
大体时间：while on drug and up to 35 days after end of treatment
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while on drug and up to 35 days after end of treatment
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Genetic markers of kidney toxicity
大体时间：while on drug and up to 35 days after end of treatment
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while on drug and up to 35 days after end of treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Peter H O'Donnell, MD、University of Chicago
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2009年9月22日
初级完成 (实际的)
2018年3月1日
研究完成 (实际的)
2018年3月1日
研究注册日期
首次提交
2009年9月22日
首先提交符合 QC 标准的
2009年9月23日
首次发布 (估计)
2009年9月24日
研究记录更新
最后更新发布 (实际的)
2018年9月11日
上次提交的符合 QC 标准的更新
2018年9月10日
最后验证
2018年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 09-135-B
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.
urine samples (biomarkers)的临床试验
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Centre Hospitalier Universitaire de Saint Etienne完全的