Examination the Ability to Early Diagnose HCC by Combining Three Biomarkers Technology Developed by WAKO, And Their Relevance to Cirrhotic of Patients With Various Backgrounds and the Israeli Population.

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

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-08-31

Brief Summary

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Examination the ability to early diagnose HCC by combining three biomarkers technology developed by WAKO, And their relevance to cirrhotic of patients with various backgrounds and the Israeli population.

This blood test will serve as an additional diagnostic tool tools currently in use (Ultrasound and AFP levels) to cirrhotic patients with high risk to develop hepatocellular carcinoma.

Another group that will be examined for all three biomarkers will be patients which already diagnosed with hepatocellular carcinoma, and have normal AFP level in order to examine the correlation between the presence of tumor, the number of them and the tumor size and the three biomarkers concentration in their blood

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Detailed Description

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Conditions

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Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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cirrhotic patients

if positive for 3 bio-markers- will be followed by MRI for HCC diagnosis

Group Type EXPERIMENTAL

MRI

Intervention Type DEVICE

non cirrhotic patients

control group - 3 bio-markers will be measured only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MRI

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients with chronic liver disease or cirrhotic or with diagnoses HCC with HCV, HBV, NAFLD, Alcohol background

Exclusion Criteria

* patients with chronic liver disease or cirrhotic or with diagnoses HCC with autoimmune background or other background than HCV, HBV, NAFLD and Alcohol.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No