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Chronic liver disease patients who are under going standard of care surveillance for the development of HCC as defined by AASLD guidelines.

Chronic liver disease patients who are under going standard of care surveillance for the development of HCC as defined by AASLD guidelines plus the addition of biomarker assays (AFP, AFP-L3 and DCP) every 6 months.

Feld Jordan, MD

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 prothrombin (DCP), for surveillance program patients whose hepatocellular carcinoma (HCC) development may be potentially missed by ultrasound (US). This study expects to demonstrate that addition of biomarkers will increase the detection rate by at least 10%.

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 conducted initially at UHN (TGH and TWH). One arm will undergo surveillance for hepatocellular carcinoma using ultrasound (US) alone and the other will undergo HCC surveillance with US plus biomarkers (BM). The biomarkers to be used will be AFP, AFP-L3 and DCP). Subjects will undergo surveillance at 6 monthly intervals for a minimum of 2 years and up to 4 years. The endpoints will be the comparative effectiveness, defined as sensitivity and specificity of detection of HCC. The comparisons of sensitivity, specificity, and other parameters with respect to tumor characteristics will be made among US alone, biomarkers alone, and combined use of US and biomarkers. The target population is individuals who have liver cirrhosis and no HCC detectable at enrollment into the study. The factors contributing to the cause of the cirrhosis will be recorded but will not play a role into subject eligibility for the study

A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using Biomarkers

A Randomized Controlled Trial to Determine the Role of Biomarkers in Surveillance for Hepatocellular Carcinoma (HCC)

Biomarker assay levels that exceed threshold will trigger diagnostic imaging for HCC. Ultrasound imaging indicating a suspicious nodule may also trigger diagnostic imaging.

When the total number of HCC cases as diagnosed by CT/MRI have been observed. Approximately 300 cases in total half (150) the cases from each group

Wako Life Sciences

Study title	NCT ID	Conditions	Eligibility	Organization
A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using Biomarkers	NCT02272504	Cirrhosis Chronic Liver D...	18 Years -	Wako Life Sciences
A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using Biomarkers	NCT02272504	Cirrhosis Chronic Liver D...	18 Years -	Wako Life Sciences
A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using Biomarkers	NCT02272504	Cirrhosis Chronic Liver D...	18 Years -	Wako Life Sciences

Spots Global Cancer Trial Database for dcp

Every month we try and update this database with for dcp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dcp

Every month we try and update this database with for dcp cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dcp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.