Clinical trial NCT03083002: Risk of Hepatocellular Carcinoma in Patient With Liver Cirrhosis
Official title: Study of Hepatocellular Carcinoma Risk in Patient With Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Hepatocellular
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Transcriptomics characterization of liver tissue: the purpose is molecular evaluation of possible predisposing factors to development of hepatocellular carcinoma in patients with cirrhosis.
timeFrame: December 2017
Secondary outcomes:
measure: 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.
timeFrame: DECEMBER 2017
measure: 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
timeFrame: DECEMBER 2017
measure: 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.
timeFrame: DECEMBER 2017
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Di Modena
state: MO
Study officials:
affiliation: Università di Modena e Reggio Emilia
name: ERICA VILLA
role: PRINCIPAL_INVESTIGATOR
References: