Evaluation of Tissue and Circulating microRNA Profiles in Patients With Hepatocellular Carcinoma Subjected to Thermal Ablation

IRCCS Azienda Ospedaliero-Universitaria di Bologna150 enrolled

Overview

The main objectives of this research project concern the identification of microRNAs circulating and of serum metabolites predictive of treatment response in patients with early stage hepatocellular carcinoma undergoing locoregional treatment with thermoablation. In addition, the molecular mechanisms involved in reprogramming will be identified metabolic via bioinformatics analysis and pretreatment liver biopsy analysis and analysis of screening on patient-derived primary lines for personalized therapy.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Hepatocarcinoma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 * Diagnosis of hepatocarcinoma confirmed by radiology (LIRADS criteria/triphasic diagnostics) or by biopsy. * Indication for thermoablation treatment (for radiofrequency) based on the judgment of the hepatologist/surgeon. * Informed consent signed by the patient. Exclusion Criteria: * Presence of metastatic liver lesions of other origins. * History of liver transplant. * Severe, uncorrectable coagulopathy, contraindicating liver biopsy (where necessary) or ablative procedure. * Patient refusal to participate in the study or inability to obtain informed consent. * Pregnant women.

Locations (1)

IRCCS Policlinico di Sant'Orsola

Outcomes

Primary Outcomes

circulant microRNA

micro-RNAs differentially expressed between the complete response and disease residue groups

Time frame: At baseline, at 24 hours, 1 month, 3 months

tissue microRNA

micro-RNAs differentially expressed between the complete response and disease residue groups

Time frame: At baseline

Metabolomic analysis

Identification of circulating metabolites differentially expressed between the complete response and disease residue groups

Time frame: At baseline, 24 hours, 1 month, 3 months

Secondary Outcomes

Relapse Free Survival

0-1

Time frame: 24 hours, 1 month, 3 months

Overall Survival

0-1

Time frame: 24 hours, 1 month, 3 months

Hepatocarcinoma recurrence

Ecography

Time frame: 24 hours, 1 month, 3 months

Evaluation of Tissue and Circulating microRNA Profiles in Patients With Hepatocellular Carcinoma Subjected to Thermal Ablation

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts