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

NCT07601464 | Recruiting

• 1 other identifier: TERMOMIRNA
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocarcinoma

Keywords

hepatocarcinoma; liver cancer; microRNA; thermoablation

Outcome Measures

Primary Outcomes (3)

• circulant microRNA

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

  At baseline, at 24 hours, 1 month, 3 months

• tissue microRNA

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

  At baseline

• Metabolomic analysis

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

  At baseline, 24 hours, 1 month, 3 months

Secondary Outcomes (3)

• Relapse Free Survival

  24 hours, 1 month, 3 months

• Overall Survival

  24 hours, 1 month, 3 months

• Hepatocarcinoma recurrence

  24 hours, 1 month, 3 months

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Policlinico di Sant'Orsola

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, liver biopsy

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Andrea Boccatonda, MD

CONTACT

+39 0512143265; andrea.boccatonda@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: May 22, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

IT (1)