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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-64
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients diagnosed with HCC and indicated for thermoablation for liver lesions size ≤5 cm.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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
2

tissue microRNA

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

Time frame
At baseline
3

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

1

Relapse Free Survival

0-1

Time frame
24 hours, 1 month, 3 months
2

Overall Survival

0-1

Time frame
24 hours, 1 month, 3 months
3

Hepatocarcinoma recurrence

Ecography

Time frame
24 hours, 1 month, 3 months

Other outcomes

Sponsors and contacts

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