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.
Not Applicable
- Conditions
- Fibrosis
- Interventions
- Device: MRI
- Registration Number
- NCT02826005
- Lead Sponsor
- Ilex Medical
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cirrhotic patients MRI if positive for 3 bio-markers- will be followed by MRI for HCC diagnosis
- Primary Outcome Measures
Name Time Method Diagnosis of HCC in cirrhotic patients with positive values of the bio-markers by MRI within 3 years from the bio-markers examination
- Secondary Outcome Measures
Name Time Method