Hepatocellular Carcinoma Growth and Molecular Aggressiveness (UniRer)

September 29, 2012 updated by: Prof. Facchinetti Fabio

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Modena, Italy, 41124
    - Azienda Ospedaliero-Universitaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cirrhotic patients, at first diagnosis of HCC and potential liver transplant candidates

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival Time Frame: 2 years	Survival will be compared between patients with rapidly and slowly growing HCCs	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to therapy Time Frame: 2 years	Response to therapy (liver transplant, resection, TACE) will be compared between rapidly and slowly growing HCCs	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Facchinetti Fabio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

July 29, 2012

First Submitted That Met QC Criteria