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NCT04925362Not yet recruiting

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

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)

Source: ClinicalTrials.gov · Last updated 14 Jun 2021 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
900 (estimated)
First submitted
24 Feb 2021
Start date
Jun 2021
Primary completion date
Jun 2036
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT04925362

What you commit to

  • Study type: Interventional
  • Planned participants: 900
  • From Jun 2021 to the primary completion date, Jun 2036
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • 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

Other

  • Refusal or inability (lack of capacity) to give informed consent.
  • 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

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.