Evaluation of Tissue and Circulating microRNA Profiles in Patients With Hepatocellular Carcinoma Subjected to Thermal Ablation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatocarcinoma. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- circulant microRNA [Time frame: At baseline, at 24 hours, 1 month, 3 months]
- tissue microRNA [Time frame: At baseline]
- Metabolomic analysis [Time frame: At baseline, 24 hours, 1 month, 3 months]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Policlinico di Sant'Orsola — Bologna
Identifiers
NCT: NCT07601464 · TERMOMIRNA