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NCT Number: NCT07601464

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

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.

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Key information

Conditions

Hepatocarcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico di Sant'Orsola

Bologna, Emilia-Romagna, 40138, Italy

Location status: Recruiting

Location contact

Andrea Boccatonda, MD

CONTACT

[email protected]

+39 0512143265

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. tissue microRNA

    Time frame: At baseline

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

  3. 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

Secondary outcomes

  1. Relapse Free Survival

    Time frame: 24 hours, 1 month, 3 months

    0-1

  2. Overall Survival

    Time frame: 24 hours, 1 month, 3 months

    0-1

  3. Hepatocarcinoma recurrence

    Time frame: 24 hours, 1 month, 3 months

    Ecography

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Boccatonda, MD

CONTACT

[email protected]

+39 0512143265

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: TERMOMIRNA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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