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.

NCT02826005 | Unknown

• 1 other identifier: WAKOHCC2016
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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

Conditions

Fibrosis

Outcome Measures

Primary Outcomes (1)

• Diagnosis of HCC in cirrhotic patients with positive values of the bio-markers by MRI

  within 3 years from the bio-markers examination

Study Arms (2)

cirrhotic patients

EXPERIMENTAL

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

Device: MRI

non cirrhotic patients

NO INTERVENTION

control group - 3 bio-markers will be measured only

Interventions

MRI DEVICE

cirrhotic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ilex Medical: lead

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2016
• First Posted: July 7, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: July 12, 2016

Record last verified: 2016-07