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

NCT ID: NCT03429530

Last Updated: 2018-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-15

Study Completion Date

2019-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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miRna in HCC

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group1

20 patients with chronic HCV

No interventions assigned to this group

GroupII

20 patient with chronic HCV related liver cirrhosis

No interventions assigned to this group

GroupIII

40 patients with chronic HCV related liver cirrhosis complicated by hepatocellular cacinoma

No interventions assigned to this group

group IV

20 healthy blood donors will also be included as a control group

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HMHamed

OTHER

Sponsor Role lead

Responsible Party

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HMHamed

DR Hager

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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miRNA in HCC

Identifier Type: -

Identifier Source: org_study_id

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