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

May 15, 2026 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Recruiting
        • IRCCS Policlinico di Sant'Orsola
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
circulant microRNA
Time Frame: At baseline, at 24 hours, 1 month, 3 months
micro-RNAs differentially expressed between the complete response and disease residue groups
At baseline, at 24 hours, 1 month, 3 months
tissue microRNA
Time Frame: At baseline
micro-RNAs differentially expressed between the complete response and disease residue groups
At baseline
Metabolomic analysis
Time Frame: At baseline, 24 hours, 1 month, 3 months
Identification of circulating metabolites differentially expressed between the complete response and disease residue groups
At baseline, 24 hours, 1 month, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse Free Survival
Time Frame: 24 hours, 1 month, 3 months
0-1
24 hours, 1 month, 3 months
Overall Survival
Time Frame: 24 hours, 1 month, 3 months
0-1
24 hours, 1 month, 3 months
Hepatocarcinoma recurrence
Time Frame: 24 hours, 1 month, 3 months
Ecography
24 hours, 1 month, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

May 15, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TERMOMIRNA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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