Risk of Hepatocellular Carcinoma in Patient With Liver Cirrhosis

Carcinoma, Hepatocellular Clinical Trial

Official title:

Study of Hepatocellular Carcinoma Risk in Patient With Liver Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03083002
• Other study ID #: UNIRER 2
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2017
• Last updated: September 12, 2017
• Start date: May 2013
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: University of Modena and Reggio Emilia
• Contact: ERICA VILLA, MD
• Phone: +39 0594225308
• Email: erica.villa[@]unimore.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Purpose of the study is to determine transcriptomics, metabolomics and proteomics features of liver cirrhotic tissue in patients with hepatocellular carcinoma (HCC) and to find a correlation with the risk of developing HCC and survival.

Description:

Patients will be enrolled after hepatic ultrasonography control and they will be submitted to hepatic vein pressure gradient and liver biopsy.

The study have four research lines:

Task # 1: transcriptomic characterization of liver tissue. During hepatic vein pressure gradient , liver tissue will be extracted with transjugular catheter equipped with a biopsy device. Tissue will be used to extract microRNA to define molecular signature.

Task # 2: Proteomic characterization of liver tissue. Protein expression changes will be analyze with MALDI-TOF

Task # 3: Metabolomic features on serum of patient with cirrhosis. Metabolomics is defined as the quantitative measurement of the dynamic multiparametric response of living systems to pathophysiological stimulus or genetic modification. Principal objective of this activity will be identify metabolites deregulated with metabolomic approach and clarify any new pathways involved in the evolution of cirrhosis to hepatocellular carcinoma.

The metabolomic analysis will be performed on sera collected in patients with cirrhosis at baseline.

Task # 4: Transcriptomic characteristics of newly diagnosed HCC. New diagnosis of hepatocellular carcinoma will undergo an eco-assisted liver biopsy. A tissue sample will be dedicated to the extraction of 'RNA. Patients will then undergo elective treatment according to international guidelines. The course of the disease and the results of therapeutic interventions will be recorded and correlated with the molecular data. Molecular signature will be obtain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Obtaining written informed consent

• Liver cirrhosis

• Aged between 18 and 75 years

• Absence of exclusion criteria

Exclusion Criteria:

• HCC

• HIV

• Pregnancy

• Portal vein thrombosis

• Liver Transplant

• Patients' refusal to participate in clinical research

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Liver Cirrhosis

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Policlinico Di Modena	Modena	MO

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcriptomics characterization of liver tissue: the purpose is molecular evaluation of possible predisposing factors to development of hepatocellular carcinoma in patients with cirrhosis.	RNA sample will be collected from patients and used to obtained transcriptomic profile through microarray and microRNA. Patients will be submitted to hepatic vein pressure gradient and combined right heart catheterization. During this standard procedure liver tissue will be taken and treated for extraction of RNA.; In order to obtain microarray RNA extracted will be analyzed with single color hybridization of human RNA on Agilent Whole Human Genome Oligo whereas, the extraction of microRNA will be made starting from RNA extracted with mirVana miRNA Isolation kit.	December 2017
Secondary	Proteomic characterization of liver tissue: the objective is to understand if there is a relationship between emergence of HCC and alterations of protein expression in cirrhotic liver.	Modifications of protein expression will be examined by two-dimensional electrophoresis and MALDI-TOF.	DECEMBER 2017
Secondary	Metabolomic features of patient with cirrhosis: principal aim of this task is to identify particular metabolites and potential new pathway involved in the evolution of cirrhosis to hepatocellular carcinoma	Analysis will be conducted on sera collected during the screening. These samples will be examined using liquid chromatography and mass spectrometry in order to obtain the identification of main components and their mass than, the informations will be analyzed by MarkerLynxTM software	DECEMBER 2017
Secondary	Transcriptomics characteristics of newly diagnosed hepatocellular carcinoma: the purpose is to verify if we can predict the survival of patients considering the molecular features of HCC at first diagnosis.	Patients with new diagnosis of hepatocellular carcinoma will be subjected to liver biopsy. A part of biopsy will be used to extract RNA and we will try to identify molecular signature through qRT / PCR (polymerase chain reaction) and using a set of 12 up- regulated and 10 down - regulated genes previously identified.	DECEMBER 2017