Risk of Hepatocellular Carcinoma in Patient With Liver Cirrhosis
Study of Hepatocellular Carcinoma Risk in Patient With Liver Cirrhosis
研究概览
地位
条件
详细说明
Patients will be enrolled after hepatic ultrasonography control and they will be submitted to hepatic vein pressure gradient and liver biopsy.
The study have four research lines:
Task # 1: transcriptomic characterization of liver tissue. During hepatic vein pressure gradient , liver tissue will be extracted with transjugular catheter equipped with a biopsy device. Tissue will be used to extract microRNA to define molecular signature.
Task # 2: Proteomic characterization of liver tissue. Protein expression changes will be analyze with MALDI-TOF
Task # 3: Metabolomic features on serum of patient with cirrhosis. Metabolomics is defined as the quantitative measurement of the dynamic multiparametric response of living systems to pathophysiological stimulus or genetic modification. Principal objective of this activity will be identify metabolites deregulated with metabolomic approach and clarify any new pathways involved in the evolution of cirrhosis to hepatocellular carcinoma.
The metabolomic analysis will be performed on sera collected in patients with cirrhosis at baseline.
Task # 4: Transcriptomic characteristics of newly diagnosed HCC. New diagnosis of hepatocellular carcinoma will undergo an eco-assisted liver biopsy. A tissue sample will be dedicated to the extraction of 'RNA. Patients will then undergo elective treatment according to international guidelines. The course of the disease and the results of therapeutic interventions will be recorded and correlated with the molecular data. Molecular signature will be obtain.
研究类型
注册 (预期的)
联系人和位置
学习地点
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MO
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Modena、MO、意大利、41124
- 招聘中
- Azienda Ospedaliera Universitaria Policlinico Di Modena
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接触：
- ERICA VILLA, MD
- 电话号码：0594225308
- 邮箱：erica.villa@unimore.it
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接触：
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首席研究员：
- ERICA VILLA, MD
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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
Patients with liver cirrhosis will be selected. After obtaining informed consent they will be submitted to hepatic biopsy,blood sample, HVPG with combined right heart catheterization and every 6 months to ultrasound.
Patients will be followed for 24 months thereafter or until the diagnosis of HCC, whichever comes first. In case of onset of HCC, will be performed a eco-guided biopsy.
描述
Inclusion Criteria:
- Obtaining written informed consent
- Liver cirrhosis
- Aged between 18 and 75 years
- Absence of exclusion criteria
Exclusion Criteria:
- HCC
- HIV
- Pregnancy
- Portal vein thrombosis
- Liver Transplant
- Patients' refusal to participate in clinical research
学习计划
研究是如何设计的？
设计细节
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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Transcriptomics characterization of liver tissue: the purpose is molecular evaluation of possible predisposing factors to development of hepatocellular carcinoma in patients with cirrhosis.
大体时间：December 2017
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RNA sample will be collected from patients and used to obtained transcriptomic profile through microarray and microRNA. Patients will be submitted to hepatic vein pressure gradient and combined right heart catheterization. During this standard procedure liver tissue will be taken and treated for extraction of RNA. In order to obtain microarray RNA extracted will be analyzed with single color hybridization of human RNA on Agilent Whole Human Genome Oligo whereas, the extraction of microRNA will be made starting from RNA extracted with mirVana miRNA Isolation kit. |
December 2017
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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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Proteomic characterization of liver tissue: the objective is to understand if there is a relationship between emergence of HCC and alterations of protein expression in cirrhotic liver.
大体时间：DECEMBER 2017
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Modifications of protein expression will be examined by two-dimensional electrophoresis and MALDI-TOF.
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DECEMBER 2017
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Metabolomic features of patient with cirrhosis: principal aim of this task is to identify particular metabolites and potential new pathway involved in the evolution of cirrhosis to hepatocellular carcinoma
大体时间：DECEMBER 2017
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Analysis will be conducted on sera collected during the screening.
These samples will be examined using liquid chromatography and mass spectrometry in order to obtain the identification of main components and their mass than, the informations will be analyzed by MarkerLynxTM software
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DECEMBER 2017
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Transcriptomics characteristics of newly diagnosed hepatocellular carcinoma: the purpose is to verify if we can predict the survival of patients considering the molecular features of HCC at first diagnosis.
大体时间：DECEMBER 2017
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Patients with new diagnosis of hepatocellular carcinoma will be subjected to liver biopsy.
A part of biopsy will be used to extract RNA and we will try to identify molecular signature through qRT / PCR (polymerase chain reaction) and using a set of 12 up- regulated and 10 down - regulated genes previously identified.
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DECEMBER 2017
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合作者和调查者
调查人员
- 首席研究员：ERICA VILLA、Università di Modena e Reggio Emilia
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
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
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