HepatocarcinomaTERMOMIRNANCT07601464
Evaluation of Tissue and Circulating microRNA Profiles in Patients With Hepatocellular Carcinoma Subjected to Thermal Ablation
An observational study of Hepatocarcinoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Hepatocarcinoma
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 26 Mar 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Adult
Study population: Patients diagnosed with HCC and indicated for thermoablation for liver lesions size ≤5 cm.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico di Sant'Orsola
Bologna, Emilia-Romagna, 40138
Andrea Boccatonda, MD, +39 0512143265, andrea.boccatonda@aosp.bo.it
About this study
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
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
circulant microRNA
micro-RNAs differentially expressed between the complete response and disease residue groups
Measured: At baseline, at 24 hours, 1 month, 3 months
tissue microRNA
micro-RNAs differentially expressed between the complete response and disease residue groups
Measured: At baseline
Metabolomic analysis
Identification of circulating metabolites differentially expressed between the complete response and disease residue groups
Measured: At baseline, 24 hours, 1 month, 3 months
Secondary outcomes (3)
Relapse Free Survival
0-1
Measured: 24 hours, 1 month, 3 months
Overall Survival
0-1
Measured: 24 hours, 1 month, 3 months
Hepatocarcinoma recurrence
Ecography
Measured: 24 hours, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start26 Mar 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatocarcinomaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601464
- Sponsor's protocol ID
- TERMOMIRNA
- Acronym
- TERMOMIRNA
- Status last verified
- May 2026
- First submitted
- 3 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tissue and Circulating microRNA Profiles in Patients With Hepatocellular Carcinoma Subjected to Thermal Ablation
- ClinicalTrials.gov ID
- NCT07601464
- Acronym / sponsor ID
- TERMOMIRNA / TERMOMIRNA
- Conditions
- Hepatocarcinoma
- Keywords
- hepatocarcinoma, liver cancer, microRNA, thermoablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients diagnosed with HCC and indicated for thermoablation for liver lesions size ≤5 cm.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
tissue microRNA
Time frame: At baseline
micro-RNAs differentially expressed between the complete response and disease residue groups
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
3 secondary outcomes
Relapse Free Survival
Time frame: 24 hours, 1 month, 3 months
Overall Survival
Time frame: 24 hours, 1 month, 3 months
Hepatocarcinoma recurrence
Time frame: 24 hours, 1 month, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocarcinoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Boccatonda, MD (+39 0512143265, andrea.boccatonda@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circulant microRNA (time frame: At baseline, at 24 hours, 1 month, 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.