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.

Examination the Ability to Early Diagnose HCC

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

Study Overview

• Status: Unknown
• Conditions: Fibrosis
• Intervention / Treatment: Device: MRI

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cirrhotic patients; if positive for 3 bio-markers- will be followed by MRI for HCC diagnosis	Device: MRI
No Intervention: non cirrhotic patients; control group - 3 bio-markers will be measured only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnosis of HCC in cirrhotic patients with positive values of the bio-markers by MRI	within 3 years from the bio-markers examination

Collaborators and Investigators

• Sponsor: Ilex Medical

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: July 4, 2016
• First Submitted That Met QC Criteria: July 4, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Estimate): July 12, 2016
• Last Update Submitted That Met QC Criteria: July 11, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: WAKOHCC2016