Hepatocellular Carcinoma Growth and Molecular Aggressiveness (UniRer)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01657695
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : October 2, 2012
Information provided by (Responsible Party):
Prof. Facchinetti Fabio, University of Modena and Reggio Emilia

Brief Summary:
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.

Condition or disease
Cirrhosis Hepatocellular Carcinoma

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
Actual Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: "Integrated Molecular/Imaging Technology for Characterization of Biological Aggressiveness of HCC in Patients Candidate to Liver Transplant"
Study Start Date : June 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Survival [ Time Frame: 2 years ]
    Survival will be compared between patients with rapidly and slowly growing HCCs

Secondary Outcome Measures :
  1. Response to therapy [ Time Frame: 2 years ]
    Response to therapy (liver transplant, resection, TACE) will be compared between rapidly and slowly growing HCCs

Biospecimen Retention:   Samples With DNA
We have designed custom arrays selecting those genes that, on the basis of literature and our own data, will be most informative regarding molecular pathways of relevance for HCC onset and progression and which have been already associated with decreased survival. These genes belong to cell cycle, apoptosis, cell proliferation, cell signaling, hypoxia and metastasis-prone pathways.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cirrhotic patients, at first diagnosis of HCC and potential liver transplant candidates

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01657695

Azienda Ospedaliero-Universitaria
Modena, Italy, 41124
Sponsors and Collaborators
Prof. Facchinetti Fabio
Principal Investigator: Erica Villa, MD University of Modena and Reggio Emilia

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Facchinetti Fabio, Clinical Professor, University of Modena and Reggio Emilia Identifier: NCT01657695     History of Changes
Other Study ID Numbers: 10/08_CE_UniRer
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: October 2, 2012
Last Verified: September 2012

Keywords provided by Prof. Facchinetti Fabio, University of Modena and Reggio Emilia:
Computed tomography
Gene expression
Fractional growth

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Behavioral Symptoms