Hepatocellular Carcinoma Clinical Trial
Official title:
Hepatic and Circulating microRNAs miR-221 and miR-222 Expression and Its Clinical Significance in Hepatocellular Carcinoma (HCC)
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 10, 2018 |
Est. primary completion date | December 10, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - hepatocellular carcinoma, not eligible for liver transplant undergoing surgical resection Exclusion Criteria: - extrahepatic disease, other primary tumour |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Fiammetta Soggiu | Aberdeen |
Lead Sponsor | Collaborator |
---|---|
University of Aberdeen | Robert Gordon University |
United Kingdom,
Gramantieri 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. — View Citation
Li 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. — View Citation
Qi 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | presence of miR-221 and mR-222 in the blood | To evaluate the presence of miR-221 and mR-222 in the blood of patients with HCC compared to age-matched healthy controls | 6 months | |
Secondary | correlation of expression of miR-221 and miR-222 in tissue and blood samples | To evaluate the correlation between the expression of miR-221 and miR-222 in tissue and blood samples in patients with HCC | 6 months |
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