Back to resultsExamination 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.
Primary Purpose
Fibrosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Fibrosis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
cirrhotic patients
non cirrhotic patients
Arm Description
if positive for 3 bio-markers- will be followed by MRI for HCC diagnosis
control group - 3 bio-markers will be measured only
Outcomes
Primary Outcome Measures
Diagnosis of HCC in cirrhotic patients with positive values of the bio-markers by MRI
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02826005
Brief Title
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.
Official Title
Examination the Ability to Early Diagnose HCC
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ilex Medical
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cirrhotic patients
Arm Type
Experimental
Arm Description
if positive for 3 bio-markers- will be followed by MRI for HCC diagnosis
Arm Title
non cirrhotic patients
Arm Type
No Intervention
Arm Description
control group - 3 bio-markers will be measured only
Intervention Type
Device
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
Diagnosis of HCC in cirrhotic patients with positive values of the bio-markers by MRI
Time Frame
within 3 years from the bio-markers examination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
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.
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