NAFLDFreSHNCT03695796
French Cohort for the Study of Non-invasive Tests of Liver Lesions in NAFLD/NASH (FreSH Cohort)
A study testing biopsy-proven NAFLD patients with non-invasive tests of liver fibrosis (blood tests, elastography devices) and biobank in people with NAFLD, run by University Hospital, Angers at 16 sites in 2 countries.
Trial summary
Currently, the management of non-alcoholic fatty liver disease (NAFLD) patients has two main limitations. First, there is no approved treatment in NAFLD. Second, liver biopsy remains the reference procedure for the evaluation of liver lesions but it is invasive and can't be proposed to all NAFLD patients who represent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NAFLD
- What is being tested?
- biopsy-proven NAFLD patients with non-invasive tests of liver fibrosis (blood tests, elastography devices) and biobank
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,005 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 22 Nov 2018to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
France15 sites
Amiens University Hospital
Amiens
University Hospital of Besançon
Besançon
University Hospital of Clermont-Ferrand
Clermont-Ferrand
Grenoble University Hospital
Grenoble
Hospital of Le Havre
Le Havre
University Hospital of Lille
Lille
Hospital Center Of Lorient
Lorient
Edouard Herriot Hospital
Lyon
Saint-Joseph Hospital
Marseille
University Hospital Of Nice
Nice
University of Bordeaux
Pessac
University Hospital of Rouen
Rouen
University Hospital of Strasbourd
Strasbourg
University Hospital of Toulouse
Toulouse
University Hospital Of Nancy
Vandœuvre-lès-Nancy
About this study
Currently, the management of non-alcoholic fatty liver disease (NAFLD) patients has two main limitations. First, there is no approved treatment in NAFLD. Second, liver biopsy remains the reference procedure for the evaluation of liver lesions but it is invasive and can't be proposed to all NAFLD patients who represent 25% of the general population. Phase III trials have recently started in NAFLD with the hope of new treatments available in few years on the market. Consequently, we now need to develop and validate the non-invasive tools that will allow the identification of the subset of NAFLD patients who will benefit from treatment with the new drugs once they will be available in clinical practice.
We aim to generate of large multicenter cohort of biopsy-proven NAFLD patients including non-invasive tests of liver lesions (blood tests, elastography devices) and a biobank to promote a research network in the field of non-invasive diagnosis of liver lesions in NAFLD. Eight French centers highly experienced in this field of research will participate to the cohort.
Our primary aim will be to evaluate and improve the non-invasive diagnosis of liver fibrosis in NAFLD. The primary endpoint will be advanced fibrosis as defined by fibrosis stages F3/4 by the NASH-CRN histological semi-quantitative scoring
- Conditions
- NAFLD
- Being tested
- biopsy-proven NAFLD patients with non-invasive tests of liver fibrosis (blood tests, elastography devices) and biobank
- Keywords
- patients with a NAFLD proven by liver biopsy
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsy-proven NAFLD patients with non-invasive tests of liver fibrosis (blood tests, elastography devices) and biobankDiagnostic test
To evaluate and improve the non-invasive diagnosis of liver fibrosis in NAFLD and to develop the non-invasive diagnosis of NASH
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Only one arm because diagnostic study evaluating non-invasive tests using liver biopsy as reference Receives: Diagnostic Test: biopsy-proven NAFLD patients with non-invasive tests of liver fibrosis (blood tests, elastography devices) and biobank |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advanced fibrosis in NAFLD
Advanced fibrosis defined by a stage of fibrosis F≥ 3 on liver biopsy according to the semi-quantitative histological classification of NASH CRN
Measured: 1 day
Secondary outcomes (9)
Non alcoholic steatohepatitis
On liver biopsy (NASH CRN classification): steatosis >=1 AND ballooning >=1 AND lobular inflammation >= 1
Measured: 1 day
Validate the diagnostic performance and thresholds of 2nd generation blood tests compared to 1st generation blood tests
Measured: 1 day
Validate the diagnostic performance and thresholds of new elastography devices for the assessment of hepatic fibrosis and steatosis
Measured: 1 day
Validate the reliability criteria for Fibroscan in NAFLD, in particular for the XL probe
Measured: 1 day
Defining reliability criteria for Acoustic Radiation Force Impulse and Supersonic Shearwave Imaging in NAFLD
Measured: 1 day
Validating the performance of the eLIFT algorithm for screening advanced liver fibrosis in NAFLD
Measured: 1 day
Assessing the prognostic value of non-invasive fibrosis tests for predicting death from liver-related causes
Measured: 1 day
Identify new biomarkers for the non-invasive diagnosis of NASH thanks to collaborations developed by the investigating centres with teams with expertise in 'omics' technologies
Measured: 1 day
Estimate the correlation between a new serum marker, phosphatydylethanol, and alcohol consumption in patients with non-alcoholic fatty liver disease
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start22 Nov 2018
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- biopsy-proven NAFLD patients
- Masking
- None (open label)
- Enrolment
- 1,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695796
- Sponsor's protocol ID
- 49RC18_0076
- Acronym
- FreSH
- Status last verified
- Sep 2025
- First submitted
- 2 Oct 2018
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Cohort for the Study of Non-invasive Tests of Liver Lesions in NAFLD/NASH (FreSH Cohort)
- ClinicalTrials.gov ID
- NCT03695796
- Acronym / sponsor ID
- FreSH / 49RC18_0076
- Conditions
- NAFLD
- Keywords
- patients with a NAFLD proven by liver biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,005 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, the management of non-alcoholic fatty liver disease (NAFLD) patients has two main limitations. First, there is no approved treatment in NAFLD. Second, liver biopsy remains the reference procedure for the evaluation of liver lesions but it is invasive and can't be proposed to all NAFLD patients who represent 25% of the general population. Phase III trials have recently started in NAFLD with the hope of new treatments available in few years on the market. Consequently, we now need to develop and validate the non-invasive tools that will allow the identification of the subset of NAFLD patients who will benefit from treatment with the new drugs once they will be available in clinical practice.
We aim to generate of large multicenter cohort of biopsy-proven NAFLD patients including non-invasive tests of liver lesions (blood tests, elastography devices) and a biobank to promote a research network in the field of non-invasive diagnosis of liver lesions in NAFLD. Eight French centers highly experienced in this field of research will participate to the cohort.
Our primary aim will be to evaluate and improve the non-invasive diagnosis of liver fibrosis in NAFLD. The primary endpoint will be advanced fibrosis as defined by fibrosis stages F3/4 by the NASH-CRN histological semi-quantitative scoring
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- biopsy-proven NAFLD patients
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Diagnostic Test: biopsy-proven NAFLD patients with non-invasive tests of liver fibrosis (blood tests, elastography devices) and biobankOnly one arm because diagnostic study evaluating non-invasive tests using liver biopsy as reference |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- NAFLD diagnosis defined by the presence of at least two of the following elements:
- Indication for liver biopsy in the clinical management of the patient
- Obtaining the signature of the consent to participate in the study
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsy-proven NAFLD patients with non-invasive tests of liver fibrosis (blood tests, elastography devices) and biobankTo evaluate and improve the non-invasive diagnosis of liver fibrosis in NAFLD and to develop the non-invasive diagnosis of NASH | Diagnostic test | Single arm |
Primary outcome
Advanced fibrosis in NAFLD
Time frame: 1 day
Advanced fibrosis defined by a stage of fibrosis F≥ 3 on liver biopsy according to the semi-quantitative histological classification of NASH CRN
9 secondary outcomes
Non alcoholic steatohepatitis
Time frame: 1 day
Validate the diagnostic performance and thresholds of 2nd generation blood tests compared to 1st generation blood tests
Time frame: 1 day
Validate the diagnostic performance and thresholds of new elastography devices for the assessment of hepatic fibrosis and steatosis
Time frame: 1 day
Validate the reliability criteria for Fibroscan in NAFLD, in particular for the XL probe
Time frame: 1 day
Defining reliability criteria for Acoustic Radiation Force Impulse and Supersonic Shearwave Imaging in NAFLD
Time frame: 1 day
Validating the performance of the eLIFT algorithm for screening advanced liver fibrosis in NAFLD
Time frame: 1 day
Assessing the prognostic value of non-invasive fibrosis tests for predicting death from liver-related causes
Time frame: 1 day
Identify new biomarkers for the non-invasive diagnosis of NASH thanks to collaborations developed by the investigating centres with teams with expertise in 'omics' technologies
Time frame: 1 day
Estimate the correlation between a new serum marker, phosphatydylethanol, and alcohol consumption in patients with non-alcoholic fatty liver disease
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsy-proven NAFLD patients with non-invasive tests of liver fibrosis (blood tests, elastography devices) and biobank in people with NAFLD, run by University Hospital, Angers at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France, Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advanced fibrosis in NAFLD (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.