Ignite Creation Date:
2024-05-06 @ 1:34 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01846949
Status:
UNKNOWN
Last Update Posted:
2021-07-21
First Post:
2013-04-23
Brief Title:
Surveillance Study for HCC by Combining Biomarkers With Imaging ALDUS
Sponsor:
ALDUS Study Group
Organization:
ALDUS Study Group
Study Overview
Official Title:
Study for Clinical Significance of Use of Alphafetoprotein AFP AFP-L3 and Des-gamma-carboxy Prothrombin DCP Versus US Alone in Surveillance for HCC
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
ENROLLING_BY_INVITATION
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:
ALDUS
Brief Summary:
This study is intended to be a prospective observational study at multiple sites not a randomized controlled trial RCT The uses of the biomarkers has been approved by government regulations and adopted for surveillance programs in some countries thus an RCT which compares patients followed by US alone with patients followed by both US and the biomarkers would raise an ethical conflict especially in countries where the biomarkers have been routinely used
For this study enrolled patients will be followed by US and the biomarkers at regular intervals and classified after completing the study to evaluate the clinical effectiveness of the biomarkers The comparisons of sensitivity specificity and other parameters with respect to tumor characteristics will be made among US alone the biomarkers and combined use of US and the biomarkers Also economical effectiveness of using the biomarkers will be investigated in this study
Requirement status is monitored every month
For this study enrolled patients will be followed by US and the biomarkers at regular intervals and classified after completing the study to evaluate the clinical effectiveness of the biomarkers The comparisons of sensitivity specificity and other parameters with respect to tumor characteristics will be made among US alone the biomarkers and combined use of US and the biomarkers Also economical effectiveness of using the biomarkers will be investigated in this study
Requirement status is monitored every month
Detailed Description:
Data are being stored in the electric data capture EDC server
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