Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients (IMPROVE Study)
IMPROVE
1 other identifier
interventional
282
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2019
CompletedFirst Posted
Study publicly available on registry
October 31, 2019
CompletedStudy Start
First participant enrolled
December 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2020
CompletedMay 18, 2022
May 1, 2022
9 months
October 29, 2019
May 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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)
1 day
Secondary Outcomes (4)
sensibility of the eLIFT test
1 day
specificity and positive predictive value of the eLIFT test
1 day
rate of liver complications among patients with an eLIFT test ≥ 8
1 day
performance of e-LIFT test in subgroup analysis
1 day
Study Arms (1)
Diagnostic Test: e-LIFT
OTHERonly one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference
Interventions
Diagnostic procedure: elastography devices, blood tests (e-LIFT), liver biopsy if necessary (elstometry ≥ 8 kPa and \< 15 kPa)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr Adrien LANNES
Angers, 49933, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2019
First Posted
October 31, 2019
Study Start
December 9, 2019
Primary Completion
September 8, 2020
Study Completion
November 26, 2020
Last Updated
May 18, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share