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

NCT04925362 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2021-06-14

No results posted yet for this study

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

Conditions

  • NAFLD
  • NASH
  • NASH - Nonalcoholic Steatohepatitis
  • Fibrosis
  • Cirrhosis

Interventions

OTHER

Biological specimens

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)

OTHER

Additional visit

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)

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Vlad RATZIU · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2036-06-30
Completion
2036-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04925362 on ClinicalTrials.gov