Ignite Creation Date:
2024-05-06 @ 3:22 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02272504
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2014-10-20
Brief Title:
A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using Biomarkers
Sponsor:
Wako Life Sciences
Organization:
Wako Life Sciences
Study Overview
Official Title:
A Randomized Controlled Trial to Determine the Role of Biomarkers in Surveillance for Hepatocellular Carcinoma HCC
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None