A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using Biomarkers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02272504|
Recruitment Status : Recruiting
First Posted : October 23, 2014
Last Update Posted : April 27, 2016
|Condition or disease|
|Cirrhosis Chronic Liver Diseases|
|Study Type :||Observational|
|Estimated Enrollment :||2500 participants|
|Observational Model:||Case Control|
|Official Title:||A Randomized Controlled Trial to Determine the Role of Biomarkers in Surveillance for Hepatocellular Carcinoma (HCC)|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||February 2019|
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.
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.
- Biomarker assays exceeding threshold [ Time Frame: Every 6 months until HCC is detected or up to 4 years ]Biomarker assay levels that exceed threshold will trigger diagnostic imaging for HCC. Ultrasound imaging indicating a suspicious nodule may also trigger diagnostic imaging.
- Surveillance until HCC development and detection [ Time Frame: Up to 4 years ]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
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272504
|Contact: Morris Sherman, MD||416 340 4756||Dr.Morris.Sherman@uhn.ca|
|Contact: Jordan Feld, MD||416 603 6230||Jordan.Feld@uhn.ca|
|Toronto General Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2C4|
|Contact: Morris Sherman, MD 416 340 4756 Dr.Morris.Sherman@uhn.ca|
|Toronto Western Hospital||Recruiting|
|Toronto, Ontario, Canada, M5T 2S8|
|Contact: Jordan Feld, MD 416 603 6230 Jordan.Feld@uhn.ca|
|Principal Investigator:||Morris Sherman, MD||Toronto General Hospital|