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临床试验/NCT01657695
NCT01657695已完成不适用

"Integrated Molecular/Imaging Technology for Characterization of Biological Aggressiveness of HCC in Patients Candidate to Liver Transplant"

Prof. Facchinetti Fabio1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
1
主要终点
Survival

研究概览

简要总结

Our long-term objective is to develop a new tool based on a (molecular-biology) integrated imaging technology able to characterize and categorize hepatocellular carcinoma (HCC) patients in need of liver transplant (LT). To this end, our study aims at correlating specific imaging traits and fractional growth of individual tumors collected over a restricted time frame (T0 and at week 7 after first tumor detection), with a "molecular signature", obtained by custom microarray, histochemical and cytokine analysis. This should allow us to translate a series of purely morphologic information into a meaningful pathobiologic data sets. Validation of the integrated molecular-imaging tool will be performed prospectively by correlating the imaging-molecular data with HCC outcome in term of survival and disease-free survival after down staging procedures.

详细描述

Organ allocation in our region is regulated according to MELD score. Patients with hepatocellular carcinoma (HCC) receive an additional score depending on size of the tumor and the time spent in transplant waiting list. However, the advantage given to these patients is uniform and does not take into account the profound biological heterogeneity of individual HCCs. To make the additional score righteous, the investigators need to identify patients with aggressively growing HCC who require salvage transplantation while those with slow-growing HCC do not deserve the additional score.

All cirrhotics with suspect HCC identified at routine US screening will be therefore enrolled in the prospective imaging and bio-molecular study.

They will be subjected to two computed tomography (CT) exams at 7 weeks interval to define fractional tumor growth and imaging traits, baseline US-guided liver biopsy for microarray and histochemical characterization, serum sampling for cytokine assay. Survival, disease-free survival after downstaging and transplant outcome will be recorded and analyzed in relation with imaging and molecular data. The investigators expect to set up an accurate imaging and molecular diagnostic tool able to identify patients with aggressive HCC requiring urgent access to transplant, reliable in predicting survival, standardisable and not too expensive.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cirrhotic patients at first US identification of a focal lesion compatible with HCC
  • Age > than 18 years
  • No contraindications to performance of CT
  • No contraindications to performance of US-guided liver biopsy

排除标准

  • Patients will be excluded if
  • are unable to give informed consent to the study;
  • liver tissue obtained at biopsy is insufficient to perform molecular/histochemical study

结局指标

主要结局

Survival

时间窗: 2 years

Survival will be compared between patients with rapidly and slowly growing HCCs

次要结局

  • Response to therapy(2 years)

研究者

发起方
Prof. Facchinetti Fabio
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Facchinetti Fabio

Clinical Professor

University of Modena and Reggio Emilia

研究点 (1)

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