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Completed

NCT Number: NCT04146636

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

e-LIFT

Diagnostic Test

Diagnostic procedure: elastography devices, blood tests (e-LIFT), liver biopsy if necessary (elstometry ≥ 8 kPa and < 15 kPa)

Primary outcomes

  1. e-LIFT negative predictive value for the diagnosis of advanced hepatic fibrosis

    Time frame: 1 day

    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 outcomes

  1. sensibility of the eLIFT test

    Time frame: 1 day

    Rate of patients with an eLIFT test ≥8 among patients with advanced hepatic fibrosis

  2. specificity and positive predictive value of the eLIFT test

    Time frame: 1 day

    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)

  3. rate of liver complications among patients with an eLIFT test ≥ 8

    Time frame: 1 day

    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

  4. performance of e-LIFT test in subgroup analysis

    Time frame: 1 day

    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)

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: IMPROVE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 31, 2019
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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