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SCREaning of Advanced Liver Fibrosis Using Non-Invasive Tests in General Population (SCREANIT)

Primary Purpose

Screening, Advanced Liver Fibrosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FIB4
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Screening focused on measuring Screening, advanced liver fibrosis, non-invasive tests

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 18 and 75 years Blood sample taken at a medical testing laboratory selected for the study. Biology without high risk of false positive result for FIB4 (AST and ALT ≤ 300 IU/l ; Platelets ≥ 50 G/l and < 500 G/l.) FIB4 > 2.67 after automatic calculation in the medical laboratory less than 3 months old Signature of informed consent to participate in the study Exclusion Criteria: Ongoing specialized follow-up for a chronic liver disease Difficulty understanding the French language Pregnant women, breastfeeding or parturient women Persons suspended from liberty by judicial or administrative decision Persons under legal protection Persons unable to express their consent Non affiliation to a social security system

Sites / Locations

  • Chu Angers
  • Chu Bordeaux
  • Chu Grenoble Alpes
  • Centre Hospitalier de Lens
  • Hopital Saint Joseph
  • Chu Nancy

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Diagnostic FIB4

Arm Description

Only one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference

Outcomes

Primary Outcome Measures

Proportion of advanced hepatic fibrosis.
The endpoint for this objective will be the diagnosis of advanced liver fibrosis is a stage of F3-4 fibrosis on liver biopsy (NASH-CRN classification), in patients with a FIB4> 2.67 and a FibroScan result ≥ 8 kPa.

Secondary Outcome Measures

Determine the rate of patients requiring second-line evaluation by elastometry
The endpoint for this objective will be the rate of patients with FIB4 >2.67.
Determine the rate of patients requiring management by a liver disease specialist.
The endpoint for this objective will be the rate of patients with a FIB4 >2.67 and then a FibroScan ≥8.0 kPa.
Determine the average cost spent on a patient diagnosed with advanced liver fibrosis
The endpoint for this objective will be the average direct cost of all procedures performed in the screening procedure.
Determine patient adherence to the screening procedure
The endpoint for this objective will be the rate of patients performing the procedures in accordance with the screening procedure.
Determine risk factors associated with advanced liver fibrosis, and consequently the subgroup of patients for whom screening should be a priority
The endpoint for this objective will be multivariate analysis of risk factors according to the stage of detected liver fibrosis
Determine the rate of patients with a significant liver complication in the population of patients with risk factors
The endpoints for this objective will be the number of diagnosed hepatocellular carcinoma and esophageal/gastric varices with bleeding risk.

Full Information

First Posted
January 6, 2023
Last Updated
May 19, 2023
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT05880173
Brief Title
SCREaning of Advanced Liver Fibrosis Using Non-Invasive Tests in General Population
Acronym
SCREANIT
Official Title
SCREaning of Advanced Liver Fibrosis Using Non-Invasive Tests in General Population
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of the study is to evaluate the pertinence of initiating screening for advanced hepatic fibrosis after a FIB4 result > 2.67 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 and/or 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 patient's 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Screening, Advanced Liver Fibrosis
Keywords
Screening, advanced liver fibrosis, non-invasive tests

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
502 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic FIB4
Arm Type
Other
Arm Description
Only one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference
Intervention Type
Diagnostic Test
Intervention Name(s)
FIB4
Intervention Description
Diagnostic procedure : FIB4 blood tests in medical analysis laboratories. If FIB4 positive, Non invasive spacialized evaluation (transient elastography and FibroMeter) by a specialist and if necessery liver biopsy, endoscopy and/or echography
Primary Outcome Measure Information:
Title
Proportion of advanced hepatic fibrosis.
Description
The endpoint for this objective will be the diagnosis of advanced liver fibrosis is a stage of F3-4 fibrosis on liver biopsy (NASH-CRN classification), in patients with a FIB4> 2.67 and a FibroScan result ≥ 8 kPa.
Time Frame
3 months maximum
Secondary Outcome Measure Information:
Title
Determine the rate of patients requiring second-line evaluation by elastometry
Description
The endpoint for this objective will be the rate of patients with FIB4 >2.67.
Time Frame
3 months maximum
Title
Determine the rate of patients requiring management by a liver disease specialist.
Description
The endpoint for this objective will be the rate of patients with a FIB4 >2.67 and then a FibroScan ≥8.0 kPa.
Time Frame
3 months maximum
Title
Determine the average cost spent on a patient diagnosed with advanced liver fibrosis
Description
The endpoint for this objective will be the average direct cost of all procedures performed in the screening procedure.
Time Frame
3 months maximum
Title
Determine patient adherence to the screening procedure
Description
The endpoint for this objective will be the rate of patients performing the procedures in accordance with the screening procedure.
Time Frame
3 months maximum
Title
Determine risk factors associated with advanced liver fibrosis, and consequently the subgroup of patients for whom screening should be a priority
Description
The endpoint for this objective will be multivariate analysis of risk factors according to the stage of detected liver fibrosis
Time Frame
3 months maximum
Title
Determine the rate of patients with a significant liver complication in the population of patients with risk factors
Description
The endpoints for this objective will be the number of diagnosed hepatocellular carcinoma and esophageal/gastric varices with bleeding risk.
Time Frame
3 months maximum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 75 years Blood sample taken at a medical testing laboratory selected for the study. Biology without high risk of false positive result for FIB4 (AST and ALT ≤ 300 IU/l ; Platelets ≥ 50 G/l and < 500 G/l.) FIB4 > 2.67 after automatic calculation in the medical laboratory less than 3 months old Signature of informed consent to participate in the study Exclusion Criteria: Ongoing specialized follow-up for a chronic liver disease Difficulty understanding the French language Pregnant women, breastfeeding or parturient women Persons suspended from liberty by judicial or administrative decision Persons under legal protection Persons unable to express their consent Non affiliation to a social security system
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clémence CANIVET, MD, PHD
Phone
(0)241353142
Ext
+33
Email
clemence.canivet@chu-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Matthieu LE LAY
Phone
(0)241355891
Ext
+33
Email
matthieu.lelay@chu-angers.fr
Facility Information:
Facility Name
Chu Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clémence CANIVET, MD, PHD
Phone
(0)241353142
Ext
+33
Email
clemence.canivet@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Marc DE SAINT LOUP
Phone
(0)241357812
Ext
+33
Email
madesaintloup@chu-angers.fr
Facility Name
Chu Bordeaux
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor DE LEDINGHEN
Phone
(0)557656995
Ext
+33
Email
victor.deledinghen@chu-bordeaux.fr
Facility Name
Chu Grenoble Alpes
City
Grenoble
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte COSTENTIN
Phone
(0)476765441
Ext
+33
Email
CCostentin@chu-grenoble.fr
Facility Name
Centre Hospitalier de Lens
City
Lens
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavien DAUTRECQUE
Phone
(0)321691213
Ext
+33
Email
flavien.dautrecque@gmail.com
Facility Name
Hopital Saint Joseph
City
Marseille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc BOURLIERE
Phone
(0)491808207
Ext
+33
Email
mbourliere@hopital-saint-joseph.fr
Facility Name
Chu Nancy
City
Nancy
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre BRONOWICKI
Phone
(0)383153359
Ext
+33
Email
jp.bronowicki@chu-nancy.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

SCREaning of Advanced Liver Fibrosis Using Non-Invasive Tests in General Population

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