Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601231
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-22
Brief Title:
To Quantify the Impact of Addition of the GAAD Score to Imaging in Patients with Chronic Liver Disease Eligible for HCC Surveillance
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Addition of GAAD Score to Imaging Surveillance for Early Identification of Liver Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADRENALIN
Brief Summary:
The goal of this prospective observational study is to test the impact of addition of the GAAD score to imaging in patients with chronic liver disease eligible for HCC surveillance The main questions it aims to answer are
Diagnostic accuracy of the GAAD score cut-off 257 3 for detection of HCC overall and by BCLC stage expressed using sensitivity specificity negative predictive value and positive predictive value
Change in GAAD score over time and proportion of patients with a GAAD score above the cut-off over time in relation to potential confounding factors eg age bilirubin levels presence of HCC
1000 participants with chronic liver disease eligible for HCC surveillance will be enrolled Data will be collected for 3 consecutive years after enrollment As per clinical practice patients will undergo standard bi-annual HCC surveillance comprising liver imaging with ultrasound or CT or MRI based on previous investigations and GAAD score assessment based on blood samples
Diagnostic accuracy of the GAAD score cut-off 257 3 for detection of HCC overall and by BCLC stage expressed using sensitivity specificity negative predictive value and positive predictive value
Change in GAAD score over time and proportion of patients with a GAAD score above the cut-off over time in relation to potential confounding factors eg age bilirubin levels presence of HCC
1000 participants with chronic liver disease eligible for HCC surveillance will be enrolled Data will be collected for 3 consecutive years after enrollment As per clinical practice patients will undergo standard bi-annual HCC surveillance comprising liver imaging with ultrasound or CT or MRI based on previous investigations and GAAD score assessment based on blood samples
Detailed Description:
None
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