- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02272504
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)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
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Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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 Criteria:
• 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Standard of care arm
Chronic liver disease patients who are under going standard of care surveillance for the development of HCC as defined by AASLD guidelines.
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Biomarker Arm
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomarker assays exceeding threshold
Time Frame: Every 6 months until HCC is detected or up to 4 years
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Biomarker assay levels that exceed threshold will trigger diagnostic imaging for HCC.
Ultrasound imaging indicating a suspicious nodule may also trigger diagnostic imaging.
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Every 6 months until HCC is detected or up to 4 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surveillance until HCC development and detection
Time Frame: Up to 4 years
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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
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Up to 4 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Feld Jordan, MD, Toronto General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WLS 13-6926
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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