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)
1 other identifier
observational
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
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participants targeted
Target at below P25 for all trials
Started Jun 2017
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2016
CompletedFirst Posted
Study publicly available on registry
October 10, 2016
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2018
CompletedOctober 25, 2017
October 1, 2016
1.5 years
October 7, 2016
October 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
correlation of expression of miR-221 and miR-222 in tissue and blood samples
6 months
Study Arms (2)
HCC Group
samples obtained from patients with HCC (hepatic tissue and blood)
Plasma control Group (PCG)
blood samples obtained from healthy controls
Interventions
Eligibility Criteria
patient affected by hepatocellular carcinoma undergoing curative surgical treatment
You may qualify if:
- hepatocellular carcinoma, not eligible for liver transplant undergoing surgical resection
You may not qualify if:
- extrahepatic disease, other primary tumour
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aberdeenlead
- Robert Gordon Universitycollaborator
Study Sites (1)
Fiammetta Soggiu
Aberdeen, AB25 2ZN, United Kingdom
Related Publications (3)
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. doi: 10.4149/neo_2013_018.
PMID: 23259781BACKGROUNDGramantieri 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: 17616664BACKGROUNDLi 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: 21295551BACKGROUND
Biospecimen
* hepatic tissue (matched tumoral/non tumoral) from patients with HCC * blood sample from patients with HCC and from healthy controls
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fiammetta Soggiu, MD
NHS Grampian
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2016
First Posted
October 10, 2016
Study Start
June 1, 2017
Primary Completion
December 10, 2018
Study Completion
December 10, 2018
Last Updated
October 25, 2017
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share