Study of microRNAs as a Diagnostic Tool for HCV-related Hepatocellular Carcinoma

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03429530

Enrollment

100

Registered

2018-02-12

Start date

2018-02-15

Completion date

2019-03-31

Last updated

2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

miRna in HCC

Brief summary

The aim of this work is to study the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma.

Detailed description

Early diagnosis of hepatocellular carcinoma can significantly improve the overall survival of HCC patients, currently available diagnostic markers are still inadequate and limited by their low sensitivity and specificity. For instance, the gold standard marker, alpha-fetoprotein (AFP), has a false negative rate up to 40% for early stage of HCC. It is worthy to mention that the level of AFP was reported in a normal range of 25% of patients with advanced HCC. These discrepancies suggest the need of discovering new reliable diagnostic markers for patients with HCC. miRNAs are small endogenous, non-coding, ssRNA that are 21-30 nucleotides in length. As for the relationship between miRNA and HCC several studies have demonstrated that the aberrant expression of specific miRNA can be detected in HCC cells and tissues. miRNAs expression profile analysis has allowed the characterization of 'identity' associated with each type of human cancer and this 'identity' is correlated with carcinogenesis, tumor progression, and response to tumor treatment.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Inclusion criteria

* RNA extraction and quantitative Real-Time PCR analysis * Diagnosis of HCV will be based on detection of anti-HCV antibodies * Diagnosis of liver cirrhosis will be based on ultrasonography, biochemically and elastography when available * Diagnosis of HCC will be based on ultrasonography, the typical criteria in triphasic multislice CT scan

Exclusion criteria

* HBV or autoimmune or metabolic liver disease * serological evidence of human immunodeficiency virus (HIV) infection * malignancy in other organs * After intervention in treatment of hepatocellular carcinoma

Design outcomes

Primary

Measure	Time frame	Description
the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma.	basline	cilculating miRNAs in serum samples of HCV related HCC, HCV related liver cirrhosis , chronic HCV and healthy control group

Outcome results