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NAFLDFRAMESNCT04925362

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

A study testing Biological specimens and Additional visit in people with NAFLD and NASH, run by Assistance Publique - Hôpitaux de Paris.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis
What is being tested?
Biological specimens and Additional visit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
No sites listed yet
Study dates
Jun 2021to Jun 2036
Phase
Interventional
Are there results?
Not yet: the study is under way

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

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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Vlad RATZIU contact

0142161001 ext. +33

vlad.ratziu@aphp.fr

About this study

Official 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)

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
Read the detailed description

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).

Being tested
Biological specimens, Additional visit
Keywords
Cohort
Medical subject headings
Non-alcoholic Fatty Liver Disease, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological specimensOther

    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 visitOther

    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)

Study groups in NCT04925362
Study groupRoleWhat they receive
PatientsOtherPatients with histologically confirmed NAFLD
Receives: Other: Biological specimens; Other: Additional visit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease severity

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

    Measured: Change of the fibrosis stage from baseline to 10 years

Secondary outcomes (12)

  1. Ballooning grade

    Measured: At baseline

  2. Lobular inflammation

    Composite scores of Lobular inflammation (Ballooning and Inflammation)

    Measured: At baseline

  3. Steatohepatitis

    Presence or Absence

    Measured: At baseline

  4. Cirrhosis

    Cirrhosis defined by either :

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

    Measured: Through study completion, an average of 10 years

  5. Obesity

    Obesity defined by either :

    1. Increased waist circumference by ethnically adjusted criteria or
    2. BMI ≥25

    Measured: Change from baseline to 10 years

  6. Type 2 diabetes

    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).

    Measured: Change from baseline to 10 years

  7. Dyslipidaemia

    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);

    Measured: Change from baseline to 10 years

  8. Cardiovascular disease

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

    Measured: Change from baseline to 10 years

  9. Necroinflammation measured by the activities component of the SAF

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

    SAF : steatosis, activity, fibrosis

    Measured: Change from baseline to 10 years

  10. Necroinflammation measured by the NAS score

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

    NAS score : NAFLD Activity Score

    Measured: Change from baseline to 10 years

  11. Fasting insulin

    Measured: Change from baseline to 10 years

  12. Insulin sensitivity

    HOMA - %s

    Measured: Change from baseline to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2021
  2. Study startJun 2021 (estimated)
  3. Primary completionJun 2036 (estimated)
  4. Study completionJun 2036 (estimated)

Resources

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
Masking
None (open label)
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04925362
Sponsor's protocol ID
APHP190417
Other IDs
2019-A01308-49
Acronym
FRAMES
Status last verified
May 2021
First submitted
24 Feb 2021
Last updated
14 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Biological specimens and Additional visit in people with NAFLD and NASH, run by Assistance Publique - Hôpitaux de Paris.

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 4 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: opening soon, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vlad RATZIU (0142161001 ext. +33, vlad.ratziu@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease severity (time frame: Change of the fibrosis stage from baseline to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04925362.

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 14 Jun 2021.

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