Status:
COMPLETED
A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using Biomarkers
Lead Sponsor:
Wako Life Sciences
Conditions:
Cirrhosis
Chronic Liver Diseases
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to evaluate the clinical effectiveness of biomarkers, alpha-fetoprotein (AFP), Lens culinaris agglutinin-reactive fraction of AFP (AFP-L3), and des-gamma-carboxy prothro...
Detailed Description
This study is a prospective randomized controlled trial (RCT) comparing surveillance for hepatocellular carcinoma with ultrasound alone versus ultrasound and standard biomarkers. The study will be con...
Eligibility Criteria
Inclusion
- Patient who is able and willing to comply with study procedures, and signed and dated informed consent is obtained.
- Patients with a clinical suspicion of cirrhosis based on the investigator's evaluation with cirrhosis confirmed by one of the following: (see below for definition of cirrhosis). Etiology of cirrhosis will not be considered in determining inclusion in the study.
- Patients aged 18 years and older.
- Hep B Risk Score \> 8 (table 1)
- Table 1 Variable Risk Score Variable Risk Score Male 2 ALT \<15 0 Female 0 ALT 15-44 1 Age 30-34 0 ALT \> 45 2 Age 35-39 1 HBeAg+ve 0 Age 40-44 2 Anti-HBe-positive 2 Age 45-49 3 HBV DNA \<300 copies/mL 0 Age 50-54 4 HBV DNA 300-9999 copies/mL 0 Age 55-59 5 HBV DNA 104 -99,000 copies/mL 3 Age 60-65 6 HBV DNA 105 - 999,999 copies/mL 5 HBV DNA \> 106 copies/mL 4
Exclusion
- • Patients who have confirmed HCC by CT/MRI when they enrolled. Patients who have previously had HCC but have been treated and have been recurrence free for 5 years are eligible.
- Patients with the other cancer(s)
- Pregnant Women
- Patients who have known diagnosis of mental incapacitation that affects their ability to consent.
- Patients who are likely to be transplanted within 1 year or MELD score greater than 20.
- Patients with total or direct bilirubin \> 3x upper limit of normal
- Patients with uncontrollable ascites
- Glomerular Filtration Rate less than 60.
- Patients with ≥ Grade II of hepatic encephalopathy
- Patients who are being treated with warfarin (DCP test values are affected by warfarin)
- Patients who have any contraindication to any of the study procedures, products used or its constituents (e.g., renal failure or contrast allergy).
- Patients who suffer from claustrophobia or who have other contraindications to MRI
- Patients with cirrhosis who were successfully treated for hepatitis C more than 3 years prior. However, patients who are on study who are treated for their hepatitis C may continue in the study.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT02272504
Start Date
August 1 2014
End Date
February 1 2021
Last Update
July 23 2024
Active Locations (2)
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1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
2
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8