Hepatocellular Carcinoma Growth and Molecular Aggressiveness

Hepatocellular Carcinoma Clinical Trial

— UniRer  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657695
• Other study ID #: 10/08_CE_UniRer
• Status: Completed
• Phase: N/A
• First received: July 29, 2012
• Last updated: September 29, 2012
• Start date: June 2008
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: August 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aggression
• Carcinoma, Hepatocellular
• Cirrhosis
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Facchinetti Fabio

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Survival will be compared between patients with rapidly and slowly growing HCCs	2 years	No
Secondary	Response to therapy	Response to therapy (liver transplant, resection, TACE) will be compared between rapidly and slowly growing HCCs	2 years	No