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Hepatocellular Carcinoma Growth and Molecular Aggressiveness (UniRer)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Facchinetti Fabio, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT01657695
First received: July 29, 2012
Last updated: September 29, 2012
Last verified: September 2012
History of Changes
  Purpose

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
Cirrhosis
Hepatocellular Carcinoma

Study Type: Observational
Study Design: 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"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Modena and Reggio Emilia:

Primary Outcome Measures:
  • Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Survival will be compared between patients with rapidly and slowly growing HCCs


Secondary Outcome Measures:
  • Response to therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 78
Study Start Date: June 2008
Study Completion Date: August 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657695

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

No publications provided

Responsible Party: Prof. Facchinetti Fabio, Clinical Professor, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT01657695     History of Changes
Other Study ID Numbers: 10/08_CE_UniRer
Study First Received: July 29, 2012
Last Updated: September 29, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Modena and Reggio Emilia:
HCC
Computed tomography
Gene expression
Fractional growth

Additional relevant MeSH terms:
Aggression
Carcinoma
Liver Cirrhosis
Fibrosis
Carcinoma, Hepatocellular
Behavioral Symptoms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Liver Diseases
Digestive System Diseases
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 16, 2013