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

Primary Purpose

NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Biological specimens

Additional visit

About this trial

This is an interventional diagnostic trial for NAFLD focused on measuring Cohort

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients

Arm Description

Patients with histologically confirmed NAFLD

Outcomes

Primary Outcome Measures

Disease severity

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

Secondary Outcome Measures

Ballooning grade

Lobular inflammation

Composite scores of Lobular inflammation (Ballooning and Inflammation)

Steatohepatitis

Presence or Absence

Cirrhosis

Cirrhosis defined by either : stage 4 of histological classification of fibrosis on liver biopsy or liver stiffness >14 kPa by elastometry

Obesity

Obesity defined by either : Increased waist circumference by ethnically adjusted criteria or BMI ≥25

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).

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);

Cardiovascular disease

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

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

Necroinflammation measured by the NAS score

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

Fasting insulin

Insulin sensitivity

HOMA - %s

Full Information

NCT ID

NCT04925362

First Posted

February 24, 2021

Last Updated

June 7, 2021

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT04925362

Brief Title

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

Acronym

FRAMES

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 2021 (Anticipated)

Primary Completion Date

June 2036 (Anticipated)

Study Completion Date

June 2036 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis, Cirrhosis

Keywords

Cohort

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients

Arm Type

Other

Arm Description

Patients with histologically confirmed NAFLD

Intervention Type

Other

Intervention Name(s)

Biological specimens

Intervention Description

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)

Intervention Type

Other

Intervention Name(s)

Additional visit

Intervention Description

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)

Primary Outcome Measure Information:

Title

Disease severity

Description

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

Time Frame

Change of the fibrosis stage from baseline to 10 years

Secondary Outcome Measure Information:

Title

Ballooning grade

Time Frame

At baseline

Title

Lobular inflammation

Description

Composite scores of Lobular inflammation (Ballooning and Inflammation)

Time Frame

At baseline

Title

Steatohepatitis

Description

Presence or Absence

Time Frame

At baseline

Title

Cirrhosis

Description

Cirrhosis defined by either : stage 4 of histological classification of fibrosis on liver biopsy or liver stiffness >14 kPa by elastometry

Time Frame

Through study completion, an average of 10 years

Title

Obesity

Description

Obesity defined by either : Increased waist circumference by ethnically adjusted criteria or BMI ≥25

Time Frame