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NCT Number: NCT04925362

THE FRENCH NATIONAL NAFLD COHORT (FRench pAtients With MEtabolic Steatosis)

The main objective of this cohort study is to determine genetic, clinical biologic and metabolic factors associated with patient heterogeneity in regards to severity of NAFLD at diagnosis as well as during the clinical course.

* at diagnosis, with the aim to better characterize patients of different severity and improve our understanding of clinical and histological heterogeneity at diagnosis * during the clinical course to better understand and predict disease progression in terms notably of fibrosis progression and progression to cirrhosis

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Key information

Conditions

NAFLD Cirrhosis Digestive System Diseases Fatty Liver Fibrosis Liver Diseases NASH NASH - Nonalcoholic Steatohepatitis Non-alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Non-alcoholic fatty liver disease (NAFLD) is considered the hepatic manifestation of metabolic syndrome and is currently the most common cause of liver disease in many developed countries worldwide.

The aim of the study is to improve the scientific knowledge on markers associated with disease severity and progression in NAFLD.

The study is a multicentre French NAFLD cohort of well-characterized patients with biological samples covering the entire spectrum of NAFLD severity (steatosis, NASH, significant fibrosis, cirrhosis, hepatocellular carcinoma).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years
  • Patients with a confirmed diagnosis of NAFLD
  • Patients affiliated to French social security
  • Written informed consent signed by the patient

Exclusion criteria

  • Refusal or inability (lack of capacity) to give informed consent.
  • Average alcohol ingestion greater than 21/14 units/week (males/females) in the preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.
  • History or presence of Type 1 diabetes mellitus.
  • Presence of any other form of chronic liver disease except NAFLD
  • Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids [>10 days], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid).
  • Any contra-indication to liver biopsy.
  • Recent (within 3 months) change in dose/regimen or introduction of Vitamin E (at a dose ≥400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline.
  • Non-French speaking/unable to access an interpreter.
  • Patients judged by the investigator to be unsuitable for inclusion in the study (e.g. judged by the physician as unlikely to be compliant with the study protocol).
  • Pregnant or breastfeeding women
  • Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom

Treatment and study plan

Biological specimens

Other

Biological specimens are collected to better characterize patients of different severity and improve our understanding of clinical and histological heterogeneity at diagnosis :

  • added for the research : blood, urine, stools
  • collected for the research : liver tissue sample, if a liver biopsy is indicated for clinical reasons (standard of care)

Additional visit

Other

Visits if possible during standard care, otherwise added by the research (If necessary the annual visit will be added by research for the collection of biological samples)

Primary outcomes

  1. Disease severity

    Time frame: Change of the fibrosis stage from baseline to 10 years

    The disease severity defined by the fibrosis stage on liver biopsy according to the semi-quantitative histological classification of NASH CRN.

Secondary outcomes

  1. Ballooning grade

    Time frame: At baseline

  2. Lobular inflammation

    Time frame: At baseline

    Composite scores of Lobular inflammation (Ballooning and Inflammation)

  3. Steatohepatitis

    Time frame: At baseline

    Presence or Absence

  4. Cirrhosis

    Time frame: Through study completion, an average of 10 years

    Cirrhosis defined by either :

    • stage 4 of histological classification of fibrosis on liver biopsy or
    • liver stiffness >14 kPa by elastometry

  5. Obesity

    Time frame: Change from baseline to 10 years

    Obesity defined by either :

    • Increased waist circumference by ethnically adjusted criteria or
    • BMI ≥25

  6. Type 2 diabetes

    Time frame: Change from baseline to 10 years

    Type 2 diabetes defined by Fasting glucose ≥100 mg/dL [5.6 mmol/L], HbA1c ≥48mmol/mol (6.5%) or previously diagnosed insulin resistance/type 2 diabetes mellitus (or on treatment).

  7. Dyslipidaemia

    Time frame: Change from baseline to 10 years

    Dyslipidaemia defined by fasting TG level ≥150 mg/dL [1.7mmol/L]; or fasting HDL <40 mg/dL [1.03 mmol/L] in males and <50 mg/dL [1.29 mmol/L] in females; or on treatment);

  8. Cardiovascular disease

    Time frame: Change from baseline to 10 years

    Cardiovascular disease defined by arterial hypertension (systolic BP ≥130 or diastolic BP ≥85 mmHg, or on antihypertensive treatment).

  9. Necroinflammation measured by the activities component of the SAF

    Time frame: Change from baseline to 10 years

    Necroinflammation measured by the activities component of the SAF classification : ranges 0 to 4

    SAF : steatosis, activity, fibrosis

  10. Necroinflammation measured by the NAS score

    Time frame: Change from baseline to 10 years

    Necroinflammation measured by the NAS score : ranges from 0 to 8

    NAS score : NAFLD Activity Score

  11. Fasting insulin

    Time frame: Change from baseline to 10 years

  12. Insulin sensitivity

    Time frame: Change from baseline to 10 years

    HOMA - %s

Study contacts

Contact information is provided by the study sponsor or research team.

Vlad RATZIU

CONTACT

[email protected]

0142161001 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Identification of Clinical and Biological Factors Determining Disease Severity and Disease Progression in NAFLD: "THE FRENCH NATIONAL NAFLD COHORT" FRAMES (FRench pAtients With MEtabolic Steatosis)

Acronym: FRAMES

Important dates

Study start
2021
Primary completion
2036
Study completion
2036
First posted
Jun 14, 2021
Registry last updated
Jun 14, 2021

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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