Health TrialsbyHealthPanel

Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients

ConditionsNon-alcoholic Fatty Liver Disease (NAFLD)Alcoholic Liver Disease (ALD)Liver Fibrosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorUniversity Hospital, Angers

About this trial

The primary objective of the SOPRANO study is to compare two blood fibrosis tests, the eLIFT and the FibroMeter, for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Excessive alcohol consumption: higher than 210 g / week (men), or 140 g / week (women)

Type 2 diabetes

at least 2 metabolic factors among BMI higher than or equal to 25 kg / m 2; Elevated blood pressure (antihypertensive drug, or systolic blood pressure higher than or equal to 130mmHg, or diastolic blood pressure higher than or equal to 85mmHg), Dyslipidemia (lipid-lowering drug, or HDL cholesterol lower to 40mg/dl (men) / 50mg/dl (women), or triglycerides higher than or equal to150mg/dl); Hyperferritinemia (higher than upper limit of normal from the laboratory)

Bright liver at ultrasonography without steatosis-inducing drug(systemic corticosteroids, tamoxifen, amiodarone, methotrexate)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • eLIFT

    Diagnostic test

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

Treatment groups

1,788 Participants
are divided into 1 treatment group
Group A: Diagnostic Test: e-LIFTOther 1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity of the eLIFT test for advanced liver fibrosis

Rate of patients with advanced liver fibrosis correctly identified by the eLIFT test

Time frame
1 day
2

Sensitivity of the Fibrometer test for advanced liver fibrosis

Rate of patients with advanced liver fibrosis correctly identified by the Fibrometer test

Time frame
1 day

Secondary outcomes

1

rate of patients referred to the specialist following the screening procedure, with eLIFT test

Rate of patients with positive screening test (eLIFT ≥8)

Time frame
1 day
2

rate of patients referred to the specialist following the screening procedure, with FibroMeter test

Rate of patients with positive screening test (FibroMeter ≥0.46)

Time frame
1 day
3

Rate of "unnecessary referrals" to the specialist with eLIFT test

Rate of patients with positive screening test (eLIFT ≥8) but without final diagnosis of ALF

Time frame
1 month
4

Rate of "unnecessary referrals" to the specialist with Fibrometer test

Rate of patients with positive screening test (FibroMeter ≥0.46) but without final diagnosis of ALF

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Angers

Lead sponsor

Source ClinicalTrials.gov
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