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

H

HMHamed

Status

Unknown

Conditions

miRna in HCC

Study type

Observational

Funder types

Other

Identifiers

NCT03429530
miRNA in HCC

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 4 patient groups

Group1
Description:
20 patients with chronic HCV
GroupII
Description:
20 patient with chronic HCV related liver cirrhosis
GroupIII
Description:
40 patients with chronic HCV related liver cirrhosis complicated by hepatocellular cacinoma
group IV
Description:
20 healthy blood donors will also be included as a control group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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