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

February 6, 2018 updated by: HMHamed
The aim of this work is to study the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will be carried out in Al-Raghy hospital (Assiut university), in collaboration with Medical Microbiology &Immunology Department.

Eighty patients with HCV related chronic liver disease will be included. GroupI; 20 patients with chronic HCV GroupII; 20 patient with chronic HCV related liver cirrhosis GroupIII; 40 patients with chronic HCV related liver cirrhosis complicated by hepatocellular cacinoma Control group: (group IV) Sex and age matched 20 healthy blood donors will also be included as a control group

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HMHamed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 15, 2018

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

February 6, 2018

First Submitted That Met QC Criteria

February 6, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • miRNA in HCC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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