NCT03083002

Risk of Hepatocellular Carcinoma in Patient With Liver Cirrhosis

Study of Hepatocellular Carcinoma Risk in Patient With Liver Cirrhosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: University of Modena and Reggio Emilia · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Carcinoma, Hepatocellular

Timeline

• Start date: 2013-05-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2017-03-17
• Last updated: 2017-09-13

Locations

1 site across 1 country: Italy