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New treatment option for Non-alcoholic Fatty Liver Disease (NAFLD)
Official title Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients
ClinicalTrials.gov ID: NCT05699018
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- NAFLD and/or ALD patient defined by at least 1 of the following criteria:
- 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...
- Bright liver at ultrasonography without steatosis-inducing drug(systemic corticosteroids, tamoxifen, amiodarone, methotrexate) Following a protocol...
You likely can't join 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
- Pregnancy, breastfeeding
- Persons in detention by judicial or administrative decision
See the full eligibility criteria
- NAFLD and/or ALD patient defined by at least 1 of the following criteria:
- 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...
- Bright liver at ultrasonography without steatosis-inducing drug(systemic corticosteroids, tamoxifen, amiodarone, methotrexate) Following a protocol amendment, the 3 last investigating primary care centres will include...
- Excessive alcohol consumption: \>210 g/week in men or \>140 g/week in women,
- AND/OR type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments,
- AND with the following stratification: 30% with excessive alcohol consumption 65% with type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments 5% with both conditions (excessive alcohol...
- Patient's agreement to have a blood sample collected in a local laboratory participating in the study
- people covered by or having the rights to medical care assurance
- Written informed consent obtained from subject
- 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
- Pregnancy, breastfeeding
- Persons in detention by judicial or administrative decision
- Person admitted to a health or social establishment for purposes other than research
- Person subject to a legal protection measure
- Person unable to express consent
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Baugé-en-Anjou, France
- Bécon-les-Granits, France
- Chalonnes-sur-Loire, France
- Combourg, France
- Liffré, France
- Montreuil-Bellay, France
- Rennes, France
- Segré, France
- Val-couesnon, France
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Baugé-en-Anjou, France; Bécon-les-Granits, France; Chalonnes-sur-Loire, France; Combourg, France; Liffré, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.