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

miRna in HCC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03429530
• Other study ID #: miRNA in HCC
• Status: Not yet recruiting
• Phase: N/A
• First received: February 6, 2018
• Last updated: February 6, 2018
• Start date: February 15, 2018
• Est. completion date: March 2019

Study information

• Verified date: February 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2019
• Est. primary completion date: February 2019
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• miRna in HCC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HMHamed

Outcome

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