Clinical trial · Observational
Clinical Significance of Hepatic and Circulating microRNAs miR-221 and miR-222 in Hepatocellular Carcinoma
Hepatic and Circulating microRNAs miR-221 and miR-222 Expression and Its Clinical Significance in Hepatocellular Carcinoma (HCC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The project did not progress as there were no findings available for the lab analysis of microRNA expression.
Summary
Brief summary (as posted)
Hepatocellular carcinoma (HCC) is the most frequent primary tumour of the liver and is the third cause of cancer-related mortality worldwide. Depending on the stage of the disease, the treatment options are surgery, liver transplantation, chemotherapy or radiotherapy. Recently, scientific research has focused on small molecules called microRNAs which are produced by human cells and can be released in the blood. They have a role in cell proliferation and are found to be dysregulated in different types of cancer. It has been shown that microRNAs have a role in the development of HCC but it is unknown if these molecules can be used as markers for diagnosis and survival in HCC. In particular, microRNAs miR-221 and miR-222 are dysregulated in the tumoral tissues in about 80% of patients with HCC. This can be assessed on tissues from liver biopsies or surgical specimens, both invasive approaches. Only few studies showed the presence of microRNAs in the blood of patients with HCC but it is unknown if there is a correlation between tumoral tissue expression and circulating levels. The aim of this study is to evaluate if these two microRNAs are expressed not only in the tumoral tissues but also in the blood from cancer patients, and in different amounts compared to circulating levels in healthy individuals. A correlation between tumoral tissue and blood levels will also be evaluated. Should this evaluation show a strong correlation and reliability of circulating microRNAs in the diagnosis and follow up of HCC, future clinical trials targeting these microRNAs and their related pathways might benefit from this being adopted as conventional practice instead of the need of assessing tissue levels from liver biopsies. The results of this pilot study will bring preliminary results as a first step for future analysis on a larger cohort of patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Analysis of microRNA expression | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- HCC Group
- description
- samples obtained from patients with HCC (hepatic tissue and blood)
- interventionNames
- Other: Analysis of microRNA expression
- label
- Plasma control Group (PCG)
- description
- blood samples obtained from healthy controls
- interventionNames
- Other: Analysis of microRNA expression
Primary outcomes (1)
- measure
- presence of miR-221 and mR-222 in the blood
- timeFrame
- 6 months
- description
- To evaluate the presence of miR-221 and mR-222 in the blood of patients with HCC compared to age-matched healthy controls
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * hepatocellular carcinoma, not eligible for liver transplant undergoing surgical resection Exclusion Criteria: * extrahepatic disease, other primary tumour
References
Publications (3)
- BACKGROUNDQi J, Wang J, Katayama H, Sen S, Liu SM. Circulating microRNAs (cmiRNAs) as novel potential biomarkers for hepatocellular carcinoma. Neoplasma. 2013;60(2):135-42. doi: 10.4149/neo_2013_018. PMID 23259781
- BACKGROUNDGramantieri L, Ferracin M, Fornari F, Veronese A, Sabbioni S, Liu CG, Calin GA, Giovannini C, Ferrazzi E, Grazi GL, Croce CM, Bolondi L, Negrini M. Cyclin G1 is a target of miR-122a, a microRNA frequently down-regulated in human hepatocellular carcinoma. Cancer Res. 2007 Jul 1;67(13):6092-9. doi: 10.1158/0008-5472.CAN-06-4607. PMID 17616664
- BACKGROUNDLi J, Wang Y, Yu W, Chen J, Luo J. Expression of serum miR-221 in human hepatocellular carcinoma and its prognostic significance. Biochem Biophys Res Commun. 2011 Mar 4;406(1):70-3. doi: 10.1016/j.bbrc.2011.01.111. Epub 2011 Feb 3. PMID 21295551