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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A01308-49 | Other Identifier | ANSM |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Other | Patients with histologically confirmed NAFLD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 :
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ballooning grade | At baseline | |
| Lobular inflammation | Composite scores of Lobular inflammation (Ballooning and Inflammation) | At baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vlad RATZIU | Contact | 0142161001 | +33 | vlad.ratziu@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Vlad RATZIU | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
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|
| 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) |
|
| Steatohepatitis | Presence or Absence | At baseline |
| Cirrhosis | Cirrhosis defined by either :
| Through study completion, an average of 10 years |
| Obesity | Obesity defined by either :
| Change from baseline to 10 years |
| 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). | Change from baseline to 10 years |
| 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); | Change from baseline to 10 years |
| Cardiovascular disease | Cardiovascular disease defined by arterial hypertension (systolic BP ≥130 or diastolic BP ≥85 mmHg, or on antihypertensive treatment). | Change from baseline to 10 years |
| 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 | Change from baseline to 10 years |
| Necroinflammation measured by the NAS score | Necroinflammation measured by the NAS score : ranges from 0 to 8 NAS score : NAFLD Activity Score | Change from baseline to 10 years |
| Fasting insulin | Change from baseline to 10 years |
| Insulin sensitivity | HOMA - %s | Change from baseline to 10 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |