Cohort study on non-invasive tests for liver lesions in NAFLD patients
French Cohort for the Study of Non-invasive Tests of Liver Lesions in NAFLD/NASH (FreSH Cohort)
This study is testing new blood tests and imaging tools to see if they can help identify liver problems in people with non-alcoholic fatty liver disease without needing a biopsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Drugs / interventions | methotrexate |
| Locations | 16 sites (Amiens and 15 other locations) |
| Trial ID | NCT03695796 on ClinicalTrials.gov |
What this trial studies
This study aims to create a large multicenter cohort of patients diagnosed with non-alcoholic fatty liver disease (NAFLD) who have undergone liver biopsy. It focuses on developing and validating non-invasive diagnostic tools, such as blood tests and elastography devices, to identify patients who may benefit from future treatments. The study will also establish a biobank to support ongoing research in non-invasive liver lesion diagnosis. By gathering data from multiple French centers, the study seeks to enhance the understanding and management of NAFLD.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with biopsy-proven NAFLD who meet specific metabolic risk factors.
Not a fit: Patients with conditions that cause steatosis due to certain medications or those with excessive alcohol consumption may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved non-invasive diagnostic methods for NAFLD, facilitating better patient management and treatment options.
How similar studies have performed: Other studies have shown promise in developing non-invasive diagnostic tools for liver diseases, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* NAFLD diagnosis defined by the presence of at least two of the following elements:
* Liver steatosis (hyperechoic liver on hepatic ultrasound, quantification \> 5.6 % by spectroscopy or MRI)
* Presence of one metabolic risk factor:
* BMI ≥ 25 kg/m2 or waist circumference ≥ 94 cm (male) / ≥ 80 cm (female)
* Antihypertensive treatment or systolic BP ≥ 130 mmHg or diastolic BP ≥ 85 mmHg
* Antidiabetic treatment or fasting blood glucose ≥ 5.6 mmol/l
* Lipid-lowering treatment or triglycerides ≥ 1.71 mmol/l or HDL cholesterol \<1.1 mmol/l (male) / \<1.3 mmol/l (female)
* Dysmetabolic hyperferritinemia
* Anomaly in the liver enzyme test or liver function tests
* Indication for liver biopsy in the clinical management of the patient
* Obtaining the signature of the consent to participate in the study
Exclusion Criteria:
* Steatogenic treatment (corticosteroids, tamoxifen, amiodarone, methotrexate)
* Excessive alcohol consumption in the last 5 years (\> 210 g / week for men or \> 140 g / week for women)
* Chronic infection with hepatitis B or C
* Any evidence of other concomitant chronic liver disease
* Decompensated cirrhosis (ascites, digestive bleeding due to varicose vein rupture, liver failure, hepatocellular failure, hepato-renal syndrome)
* Hepatocellular carcinoma
* 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
Where this trial is running
Amiens and 15 other locations
- Amiens University Hospital — Amiens, France (Recruiting)
- University Hospital of Besançon — Besançon, France (Recruiting)
- University Hospital of Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- Grenoble University Hospital — Grenoble, France (Recruiting)
- Hospital of Le Havre — Le Havre, France (Recruiting)
- University Hospital of Lille — Lille, France (Recruiting)
- Hospital Center Of Lorient — Lorient, France (Recruiting)
- Edouard Herriot Hospital — Lyon, France (Recruiting)
- Saint-Joseph Hospital — Marseille, France (Recruiting)
- University Hospital Of Nice — Nice, France (Recruiting)
- University of Bordeaux — Pessac, France (Recruiting)
- University Hospital of Pointe à Pitre — Pointe-à-Pitre, France (Recruiting)
- University Hospital of Rouen — Rouen, France (Recruiting)
- University Hospital of Strasbourd — Strasbourg, France (Recruiting)
- University Hospital of Toulouse — Toulouse, France (Recruiting)
- University Hospital Of Nancy — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Study coordinator: Jérôme BOURSIER, MD-PHD
- Email: jeboursier@chu-angers.fr
- Phone: +33241353410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.