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

18 Years
Not Enrolling
Cirrhosis, Hepatocellular Carcinoma

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Trial Information

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

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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:


Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Erica Villa, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Modena and Reggio Emilia


Italy: Ethics Committee

Study ID:




Start Date:

June 2008

Completion Date:

August 2012

Related Keywords:

  • Cirrhosis
  • Hepatocellular Carcinoma
  • HCC
  • Computed tomography
  • Gene expression
  • Fractional growth
  • Aggression
  • Carcinoma
  • Liver Cirrhosis
  • Fibrosis
  • Carcinoma, Hepatocellular