Expression Levels of Nicotinamide Metabolism-related Protein (NMAP) in Newly Diagnosed Renal Cancer and Non-renal Cancer Populations (ENRC)
2020年11月21日 更新者:Jie Ding、Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
This study aims to observe the difference between NMAP (nicotinamide metabolism associated protein) serum levels in primary diagnosed renal cancer patients and non-renal cancer patient controls, plot the ROC curve and establish appropriate cut-off values.
研究概览
研究类型
观察性的
注册 (预期的)
400
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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Shanghai
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Shanghai、Shanghai、中国、200092
- 招聘中
- Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
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接触:
- Jie NA Ding, MD
- 电话号码:86-13564315425
- 邮箱:dingjie@xinhuamed.com.cn
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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
不适用
有资格学习的性别
全部
取样方法
非概率样本
研究人群
All patients are in-hospital patients treated in Xinhua Hospital
描述
Inclusion Criteria:
- The tumor group patients were found to have renal or hepatic mass, plan to receive surgical treatment (except for radiofrequency ablation, cryoablation, etc., which were not available for pathological examination). The control group patients were ruled out of tumor based on radiological tests and commonly used tumor biomarkers
- Age ≥ 18 years old and able to provide written informed consent;
- Have not received any systemic or topical treatment for kidney/liver tumors.
- Cardiopulmonary, liver and kidney functions are able to tolerate surgery and can comply with research requirements.
Exclusion Criteria:
- The investigators believe that the subject may be unsuitable for inclusion due to severe concurrent diseases, infections, and etc.
- The subjects is known or suspected of other malignancies.
- There has been another history of malignancy in the past 5 years.
- Major surgery (surgery requiring general anesthesia) was performed within 4 weeks prior to screening visits.
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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Renal cancer group
Patients which imaging studies have found renal mass, plan to receive surgery (except for radiofrequency ablation, cryoablation, etc.), about 100.
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About 4 ml of blood draw
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Urothiasis group
Patients which imaging studies have found renal or ureteral stones, and rule out of renal mass, about 100.
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About 4 ml of blood draw
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Renal cysts group
Patients which imaging studies have found renal cysts (simple or complex) about 100.
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About 4 ml of blood draw
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Liver cancer group
Patients which imaging studies have found hepatic mass, plan to receive surgery (except for radiofrequency ablation, cryoablation, etc.), about 100.
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About 4 ml of blood draw
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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 |
---|---|---|
NMAP level study
大体时间:September 2019-September 2021
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To observe the difference in the expression level of nicotinamide metabolism related protein (NMAP) in the serum of newly diagnosed renal cancer and non-renal cancer patients.
Draw the NMAP ROC curve and establish the appropriate Cut-off value to analyze its sensitivity and specificity.
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September 2019-September 2021
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
NMAP plus other tumor biomarkers study
大体时间:September 2019-September 2021
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According to NMAP and combined with other tumor biomarkers data such as AFP, multiple regression analysis was used to map the ROC curve and establish the appropriate Cut-off value to determine whether it is capable of distinguishing kidney cancer and liver cancer.
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September 2019-September 2021
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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。
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)
2019年10月1日
初级完成 (预期的)
2022年6月30日
研究完成 (预期的)
2022年6月30日
研究注册日期
首次提交
2019年10月1日
首先提交符合 QC 标准的
2019年10月1日
首次发布 (实际的)
2019年10月2日
研究记录更新
最后更新发布 (实际的)
2020年11月24日
上次提交的符合 QC 标准的更新
2020年11月21日
最后验证
2020年11月1日
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.
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