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Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients (IMPROVE Study) (IMPROVE)

Primary Purpose

NAFLD, Alcohol-Related Disorder, Liver Fibrosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
e-LIFT
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for NAFLD

Eligibility Criteria

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

Inclusion Criteria:

  • NAFLD and/or alcoholic patient defined by ≥1 of the following criteria:

    • Excessive alcohol consumption: >210 g/week (men), >140 g/week (women)
    • Type 2 diabetes
    • ≥2 metabolic factors among: 1/BMI ≥25kg/m2; 2/elevated blood pressure (antihypertensive drug, or systolic blood pressure ≥130mmHg, or diastolic blood pressure ≥85mmHg), 3/dyslipidemia (lipid-lowering drug, or HDL cholesterol <40mg/dl (men) / <50mg/dl (women), or triglycerides ≥150mg/dl); 4/hyperferritinemia (>300 ng/ml (men)/>200 ng/ml (women))
    • Bright liver at ultrasonography without steatosis-inducing drug
  • Obtaining the signature of the consent to participate in the study

Exclusion Criteria:

  • Already ongoing specialized follow-up for a chronic liver disease
  • Altered health status with poor short-term prognosis, not compatible with a screening procedure
  • Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)
  • Acute infection
  • Inadequate understanding of the French language
  • Pregnant, breastfeeding or parturient women
  • Persons deprived of their liberty by judicial or administrative decision
  • Persons subject to legal protection measures
  • Persons unable to consent
  • Refusal to participate

Sites / Locations

  • Dr Adrien LANNES

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Diagnostic Test: e-LIFT

Arm Description

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

Outcomes

Primary Outcome Measures

e-LIFT negative predictive value for the diagnosis of advanced hepatic fibrosis
The primary outcome of the study is the negative predictive value for the diagnosis of advanced hepatic fibrosis (i.e., the rate of patients who do not actually have advanced hepatic fibrosis when the eLIFT test is <8)

Secondary Outcome Measures

sensibility of the eLIFT test
Rate of patients with an eLIFT test ≥8 among patients with advanced hepatic fibrosis
specificity and positive predictive value of the eLIFT test
Rate of patients with an eLIFT test ≥8 but without a final diagnosis of advanced hepatic fibrosis (false positives), specificity (i. e. the rate of patients with an eLIFT test < 8 among patients without advanced hepatic fibrosis) and positive predictive value of the eLIFT test (i. e. the rate of patients with effective advanced hepatic fibrosis when the eLIFT test is ≥ 8)
rate of liver complications among patients with an eLIFT test ≥ 8
Rate of patients with hepatocellular carcinoma (diagnosed by recommended radiological criteria or liver biopsy); rate of patients with gastroesophageal varices at risk of bleeding diagnosed by gastrointestinal endoscopy (according to Baveno VI rules: medium to large or small varices with red signs) among patients with an eLIFT test is ≥ 8
performance of e-LIFT test in subgroup analysis
Rates of patients with advanced hepatic fibrosis, hepatocellular carcinoma rate, gastroesophageal varicose vein rate at risk of bleeding, eLIFT test rate ≥8, sensitivity, specificity, negative predictive value, positive predictive value in each subgroup (NAFLD, alcohol and NAFLD + alcohol)

Full Information

First Posted
October 29, 2019
Last Updated
May 11, 2022
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT04146636
Brief Title
Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients (IMPROVE Study)
Acronym
IMPROVE
Official Title
Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients (IMPROVE Study)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
September 8, 2020 (Actual)
Study Completion Date
November 26, 2020 (Actual)

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 is to determine the performance of the simple eLIFT blood test for advanced liver fibrosis screening in NAFLD and/or alcoholic patients in primary care.
Detailed Description
eLIFT, is a new blood fibrosis test specifically dedicated for general practitioners with simple parameters and easy "by head" calculation. Using the recommended cut-offs (eLIFT ≥8), eLIFT sensitivity was 86%. This result position eLIFT an as interesting tool for the screening of advanced liver fibrosis in large populations. As our preliminary results come from very selected patients, i.e. patients from tertiary centres who underwent a liver biopsy, we now need to evaluate in the real condition of primary care setting whether the use of eLIFT will help general practitioners to screen advanced liver fibrosis in their asymptomatic NAFLD and alcoholic patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD, Alcohol-Related Disorder, Liver Fibrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective diagnostic study in primary care. Evaluation of a simple blood test (e-LIFT) for the diagnosis of advanced liver fibrosis. Reference for advanced liver diagnosis : composite criteria : Elastometry between 8 kPa and 15 kPa and histologic evaluation of fibrosis ≥ F3 (NASH CRN ) OR Elastometry ≥ 15 kPa
Masking
None (Open Label)
Allocation
N/A
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic Test: e-LIFT
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)
e-LIFT
Intervention Description
Diagnostic procedure: elastography devices, blood tests (e-LIFT), liver biopsy if necessary (elstometry ≥ 8 kPa and < 15 kPa)
Primary Outcome Measure Information:
Title
e-LIFT negative predictive value for the diagnosis of advanced hepatic fibrosis
Description
The primary outcome of the study is the negative predictive value for the diagnosis of advanced hepatic fibrosis (i.e., the rate of patients who do not actually have advanced hepatic fibrosis when the eLIFT test is <8)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
sensibility of the eLIFT test
Description
Rate of patients with an eLIFT test ≥8 among patients with advanced hepatic fibrosis
Time Frame
1 day
Title
specificity and positive predictive value of the eLIFT test
Description
Rate of patients with an eLIFT test ≥8 but without a final diagnosis of advanced hepatic fibrosis (false positives), specificity (i. e. the rate of patients with an eLIFT test < 8 among patients without advanced hepatic fibrosis) and positive predictive value of the eLIFT test (i. e. the rate of patients with effective advanced hepatic fibrosis when the eLIFT test is ≥ 8)
Time Frame
1 day
Title
rate of liver complications among patients with an eLIFT test ≥ 8
Description
Rate of patients with hepatocellular carcinoma (diagnosed by recommended radiological criteria or liver biopsy); rate of patients with gastroesophageal varices at risk of bleeding diagnosed by gastrointestinal endoscopy (according to Baveno VI rules: medium to large or small varices with red signs) among patients with an eLIFT test is ≥ 8
Time Frame
1 day
Title
performance of e-LIFT test in subgroup analysis
Description
Rates of patients with advanced hepatic fibrosis, hepatocellular carcinoma rate, gastroesophageal varicose vein rate at risk of bleeding, eLIFT test rate ≥8, sensitivity, specificity, negative predictive value, positive predictive value in each subgroup (NAFLD, alcohol and NAFLD + alcohol)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: NAFLD and/or alcoholic patient defined by ≥1 of the following criteria: Excessive alcohol consumption: >210 g/week (men), >140 g/week (women) Type 2 diabetes ≥2 metabolic factors among: 1/BMI ≥25kg/m2; 2/elevated blood pressure (antihypertensive drug, or systolic blood pressure ≥130mmHg, or diastolic blood pressure ≥85mmHg), 3/dyslipidemia (lipid-lowering drug, or HDL cholesterol <40mg/dl (men) / <50mg/dl (women), or triglycerides ≥150mg/dl); 4/hyperferritinemia (>300 ng/ml (men)/>200 ng/ml (women)) Bright liver at ultrasonography without steatosis-inducing drug Obtaining the signature of the consent to participate in the study Exclusion Criteria: Already ongoing specialized follow-up for a chronic liver disease Altered health status with poor short-term prognosis, not compatible with a screening procedure Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome) Acute infection Inadequate understanding of the French language Pregnant, breastfeeding or parturient women Persons deprived of their liberty by judicial or administrative decision Persons subject to legal protection measures Persons unable to consent Refusal to participate
Facility Information:
Facility Name
Dr Adrien LANNES
City
Angers
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients (IMPROVE Study)

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