Hepatocellular Carcinoma Growth and Molecular Aggressiveness

NCT01657695 | Completed

• 1 other identifier: 10/08_CE_UniRer
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis; Hepatocellular Carcinoma

Keywords

HCC; Computed tomography; Gene expression; Fractional growth

Outcome Measures

Primary Outcomes (1)

• Survival

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

  2 years

Secondary Outcomes (1)

• Response to therapy

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Facchinetti Fabio: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria

Modena, 41124, Italy

Location

Related Publications (2)

• Critelli RM, Milosa F, Romanzi A, Lasagni S, Marcelli G, Di Marco L, Pivetti A, Schepis F, Romagnoli D, Mancarella S, Dituri F, Martinez-Chantar ML, Giannelli G, Villa E. Upregulation of the oestrogen target gene SIX1 is associated with higher growth speed and decreased survival in HCV-positive women with hepatocellular carcinoma. Oncol Lett. 2022 Sep 21;24(5):395. doi: 10.3892/ol.2022.13515. eCollection 2022 Nov.

  PMID: 36276500 DERIVED

• Villa E, Critelli R, Lei B, Marzocchi G, Camma C, Giannelli G, Pontisso P, Cabibbo G, Enea M, Colopi S, Caporali C, Pollicino T, Milosa F, Karampatou A, Todesca P, Bertolini E, Maccio L, Martinez-Chantar ML, Turola E, Del Buono M, De Maria N, Ballestri S, Schepis F, Loria P, Enrico Gerunda G, Losi L, Cillo U. Neoangiogenesis-related genes are hallmarks of fast-growing hepatocellular carcinomas and worst survival. Results from a prospective study. Gut. 2016 May;65(5):861-9. doi: 10.1136/gutjnl-2014-308483. Epub 2015 Feb 9.

  PMID: 25666192 DERIVED

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.

MeSH Terms

Conditions

Fibrosis; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Erica Villa, MD

  University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 29, 2012
• First Posted: August 6, 2012
• Study Start: June 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 2, 2012

Record last verified: 2012-09

Locations

IT (1)