Brief Summary

Egypt is an endemic area of HCV.Cirrhosis and HCC are the most serious complications of chronic HCV infection.Some studies noted that the risk of HCC increased 17-fold among HCV-infected patients compared with anti-HCV negative controls. Many studies demonstrate that direct antiviral therapy seems to accelerate the development of HCC, soon after the end of treatment, in those patients at higher risk of HCC occurrence or recurrence; and preliminary reports seem to indicate that HCC developed after direct antiviral therapy has more aggressive features. These findings clearly indicate the need for aggressive and close monitoring of cirrhotic patients during and after antiviral treatment, to detect and treat HCC at their earliest occurrence. Genetic variation plays a key role in HCC susceptibility and development of the disease.Genotype distribution frequency data can be used to map single nucleotide polymorphism (SNP) diversity in a population and to examine the risk and development of specific diseases.Many reports indicate an association between SNPs in certain genes and the susceptibility and clinicopathological status of HCC. MMP-1 is an endogenous peptide enzyme that is most widely expressed in interstitial collagenase,which can degrade the extracellular matrix surrounding tumor cells. It is involved in many stages of tumorigenesis, in angiogenesis, and in suppression of tumor cell apoptosis . MMP-1 - 1607 1G/2G (rs1799750) contains a guanine insertion/deletion polymorphism at position - 1607 and is a functional (SNP) that can upregulate MMP expression. The association between the MMP-1 - 1607 1G/2G polymorphism and the emergence of several diseases including the risk for many cancers has been reported. There are results suggest that MMP-1 is overexpressed in a large proportion of patients with HCC which correlated with the disease progression and poor clinical outcome. Furthermore, MMP-1 high expression proved to be a risk factor for tumor recurrence and independent molecular marker of prognosis in HCC and may become a novel target in the strategies for the prediction of tumor progression and prognosis of this disease. Aim: Is to asses: The contribution of MMP-1-1607 genotype polymorphism to the risk of HCC on top of HCV. The relationship between MMP-1-1607 gene polymorphism with HCC in patients who received antiviral treatment to HCV.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

200

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2018

Longer than P75 for all trials

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 years study duration

First Submitted

Initial submission to the registry

October 24, 2018

Completed

5 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed

2 months until next milestone

Study Start

First participant enrolled

December 15, 2018

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed

Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

October 24, 2018

Last Update Submit

October 25, 2018

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

The level of Matrix metalloprotinease-1 genotypes polymorphism in the study population
detection by polymerase chain reaction
48 hours

Study Arms (5)

HCC with TTT

Blood sample from all HCC patients who recieved antiviral treatment for HCV will be taken to detect the MMP1-genotype polymorphism in those patients and the effect of treatment on this polymorphism.