NCT04925362

Brief 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.

  • 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
120mo left

Started Jun 2021

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Jun 2021Jun 2036

First Submitted

Initial submission to the registry

February 24, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2036

Last Updated

June 14, 2021

Status Verified

May 1, 2021

Enrollment Period

15 years

First QC Date

February 24, 2021

Last Update Submit

June 7, 2021

Conditions

NAFLDNASHNASH - Nonalcoholic SteatohepatitisFibrosisCirrhosis

Keywords

Cohort

Outcome Measures

Primary Outcomes (1)

  • Disease severity

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

    Change of the fibrosis stage from baseline to 10 years

Secondary Outcomes (12)

  • Ballooning grade

    At baseline

  • Lobular inflammation

    At baseline

  • Steatohepatitis

    At baseline

  • Cirrhosis

    Through study completion, an average of 10 years

  • Obesity

    Change from baseline to 10 years

  • +7 more secondary outcomes

Study Arms (1)

Patients

OTHER

Patients with histologically confirmed NAFLD

Other: Biological specimensOther: Additional visit

Interventions

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)

Patients
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)

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • Pregnant or breastfeeding women
  • Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseFibrosis

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vlad RATZIU

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vlad RATZIU

CONTACT

0142161001vlad.ratziu@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2021

First Posted

June 14, 2021

Study Start

June 1, 2021

Primary Completion (Estimated)

June 1, 2036

Study Completion (Estimated)

June 1, 2036

Last Updated

June 14, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share