Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05880173
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-01-06
Brief Title:
SCREaning of Advanced Liver Fibrosis Using Non-Invasive Tests in General Population
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
SCREaning of Advanced Liver Fibrosis Using Non-Invasive Tests in General Population
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
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:
SCREANIT
Brief Summary:
The main objective of the study is to evaluate the pertinence of initiating screening for advanced hepatic fibrosis after a FIB4 result 267 automatically calculated in the local laboratory and followed by a specialized hepatic evaluation
Detailed Description:
Chronic liver diseases are insidious diseases characterized by inflammation of the liver parenchyma responsible for a progressive accumulation of fibrosis until cirrhosis and hepatocellular carcinoma HCC Cirrhosis and HCC are respectively the 11th and 16th most frequent causes of death in the world and are responsible for 2 million deaths each year Cirrhosis and HCC are most often diagnosed too late with a median survival of 18-24 months
The degree of hepatic fibrosis is the main predictive factor of the risk of hepatic complications decompensation of cirrhosis HCC in chronic liver diseases
Hepatic fibrosis is described in 5 stages from F0 no fibrosis to F4 cirrhosis It is well accepted that patients with advanced hepatic fibrosis F3 and F4 are at the highest risk of developing complications of cirrhosis andor HCC It is therefore necessary to identify these patients in order to offer them specialized management
Tests have been developed over the last two decades for the non-invasive diagnosis of liver fibrosis essentially the fibrosis blood test FIB4 and liver elastometry devices fibroScan The FIB4 is a simple blood test that is easy to calculate from the usual inexpensive blood parameters ASAT ALAT platelets The recommendations of French European and American scientific societies are unanimous and recommend targeted screening for liver fibrosis in patients with hepatic risk factors using FIB4 as a first line test
To facilitate screening by general practitioners several French consortia of medical analysis laboratories have set up routine calculation of FIB4 on all biological tests including platelets AST and ALT without regard to the patients risk factors for liver disease This approach is not in concordance with the recommendations of the scientific societies targeted screening in patients with hepatic risk factors and needs to be evaluated
The purpose of this study is to evaluate if the procedure for diagnosing hepatic fibrosis implemented by some local laboratories and based on an automated calculation of FIB4 is pertinent
The degree of hepatic fibrosis is the main predictive factor of the risk of hepatic complications decompensation of cirrhosis HCC in chronic liver diseases
Hepatic fibrosis is described in 5 stages from F0 no fibrosis to F4 cirrhosis It is well accepted that patients with advanced hepatic fibrosis F3 and F4 are at the highest risk of developing complications of cirrhosis andor HCC It is therefore necessary to identify these patients in order to offer them specialized management
Tests have been developed over the last two decades for the non-invasive diagnosis of liver fibrosis essentially the fibrosis blood test FIB4 and liver elastometry devices fibroScan The FIB4 is a simple blood test that is easy to calculate from the usual inexpensive blood parameters ASAT ALAT platelets The recommendations of French European and American scientific societies are unanimous and recommend targeted screening for liver fibrosis in patients with hepatic risk factors using FIB4 as a first line test
To facilitate screening by general practitioners several French consortia of medical analysis laboratories have set up routine calculation of FIB4 on all biological tests including platelets AST and ALT without regard to the patients risk factors for liver disease This approach is not in concordance with the recommendations of the scientific societies targeted screening in patients with hepatic risk factors and needs to be evaluated
The purpose of this study is to evaluate if the procedure for diagnosing hepatic fibrosis implemented by some local laboratories and based on an automated calculation of FIB4 is pertinent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None