Score System for Prediction Risk and Early Diagnosis of HCC in HIV/HCV Patients
Obtención de un Panel de puntuación ("Score System") Para la predicción de Riesgo Individualizado y la detección Precoz de Carcinoma Hepatocelular (HCC) en Sujetos Coinfectados VIH/VHC
研究概览
地位
详细说明
Transversal study design like a "proof of concept".
Primary objective:
The main objective is try to stablish a descriptive panel (first phase of a score system) based in the conjunction or sum of several clinical and laboratory parameters (molecular and genetic factors). The aim is to detect in a fast, early and successful way those patients that presents a high risk to develop an hepatocellular carcinoma (HCC) in the future in a specific population: HIV and HCV coinfected patients. The establishment of this panel will allow clinicians set up a correct treatment decreasing the probability of liver cirrhosis and HCC.
研究类型
注册 (实际的)
联系人和位置
学习地点
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-
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Madrid、西班牙
- Hospital Ramón y Cajal
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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:
- Human immunodeficiency virus chronic infection
- Hepatitis C virus chronic infection
- No other liver viral coinfections
Exclusion Criteria:
- Alcohol consume
- Immunosuppressor or immunoactive treatment
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 |
|---|
|
Grupo 0
Null or mild fibrosis
|
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Grupo 1
Cirrhosis
|
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Grupo 2
HCC diagnosis
|
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 |
|---|---|---|
|
Sera inflammatory markers
大体时间：1 day (Routine visit to normal following in Infectious Disease Department)
|
Inflammatory markers will be measure used a Enzyme-linked Immunosorbent Assay
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1 day (Routine visit to normal following in Infectious Disease Department)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sera apoptotic markers
大体时间：1 day (Routine visit in disease following at Infectious Disease Department)
|
Apoptotic markers will be evaluated through a Enzyme-linked Immunosorbent Assay
|
1 day (Routine visit in disease following at Infectious Disease Department)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluation of genetic polymorphisms distribution between study groups of relevant genes probably implicated in the disease
大体时间：1 day (Routine visit in normal following at Infectious Disease Department)
|
Genetic polymorphisms will be evaluated using Real-Time polymerase chain reaction technique
|
1 day (Routine visit in normal following at Infectious Disease Department)
|
合作者和调查者
调查人员
- 首席研究员：Beatriz S Sastre, PhD、Fundación para la Investigación Biomédica del Hospital Ramón y Cajal
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
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.