Hepatocellular Carcinoma Growth and Molecular Aggressiveness (UniRer)
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 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"|
- Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Survival will be compared between patients with rapidly and slowly growing HCCs
- 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.
|Study Start Date:||June 2008|
|Study Completion Date:||August 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657695
|Modena, Italy, 41124|
|Principal Investigator:||Erica Villa, MD||University of Modena and Reggio Emilia|