Risk of Hepatocellular Carcinoma in Patient With Liver Cirrhosis

NCT03083002 | Unknown

• 1 other identifier: UNIRER 2
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  DECEMBER 2017

• 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

  DECEMBER 2017

• 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.

  DECEMBER 2017

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with liver cirrhosis will be selected. After obtaining informed consent they will be submitted to hepatic biopsy,blood sample, HVPG with combined right heart catheterization and every 6 months to ultrasound. Patients will be followed for 24 months thereafter or until the diagnosis of HCC, whichever comes first. In case of onset of HCC, will be performed a eco-guided biopsy.

You may qualify if:

• Obtaining written informed consent
• Liver cirrhosis
• Aged between 18 and 75 years

You may not qualify if:

• HCC
• HIV
• Pregnancy
• Portal vein thrombosis
• Liver Transplant
• Patients' refusal to participate in clinical research

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Policlinico Di Modena

Modena, MO, 41124, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Liver tissue

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

  Università di Modena e Reggio Emilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ERICA VILLA, MD

CONTACT

+39 0594225308; erica.villa@unimore.it

Study Design

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

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 17, 2017
• Study Start: May 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: September 13, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)