Screening of NASH in Oupatients Followed in Various Hospi... | NCT04282447

Studies
Screening of NASH in Oupatients Followed in Various Hospital Specialty Clinics at the University Hospital of Strasbourg

NCT04282447

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Aug 27, 2020Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Nonalcoholic Fatty Liver Disease

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 14, 2020Actual

Primary Completion Date

Aug 14, 2020Actual

Completion Date

May 2022Estimated

First Submitted Date

Feb 21, 2020

First Submission Date that Met QC Criteria

Feb 21, 2020

First Posted Date

Feb 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2020

Last Update Posted Date

Aug 27, 2020Actual

Description Module

Brief Summary

The aim of the present study is to assess, by using a simple algorithm combining FIB-4 and Fibroscan, the prevalence of NASH with advanced fibrosis in outpatients followed in various hospital specialty clinics other than hepato/gastroenterology and to examine risk factors associated with this condition. The prevalence of NASH will be investigated among 6 cohorts of outpatients followed in different hospital specialty clinics at Hôpitaux Universitaires de Strasbourg.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Measure	Description	Time Frame
Estimated prevalence of NASH with advanced fibrosis among several hospital specialty clinics	To assess the estimated prevalence of NASH , calcul of the FIB4	3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age ≥ 18 years
outpatients followed at specialty clinics in HUS and at risk of NAFLD: with at least one metabolic risk factor (overweight, diabetes mellitus, hypertension, hypertriglyceridemia) and/or elevated transaminases and/or liver steatosis on US.
endocrinology cohort : type 2 diabetes patients
infectious disease cohort : HIV positive patients
rheumatology cohort : patients with psoriasis, gout or rheumatoid arthritis
nephrology cohort : patients with chronic kidney disease such as diabetic nephropathy or hypertensive nephropathy, including those receiving hemodialysis.
cardiology cohorts: patients with history of angina, myocardial infarction, stroke or arteritis of lower limbs.
internal medicine cohort: patients with auto immune systemic diseases such as lupus, sclerosis or rheumatoid arthritis.
subjects who have given their informed consent
Subjects affiliated to a social security system

Exclusion Criteria:

alcohol consumption > 30g/d in male or > 20g/d in female in the past 6 months
history of chronic viral hepatitis
history of liver auto immune disease, genetic hemochromatosis, Wilson disease
biliary disease, bile duct obstruction
drug-induced liver injury
secondary liver cancer or other active cancer
organ graft
use of medications associated with secondary NAFLD (corticosteroids, tamoxifen, amiodarone, methotrexate).
congestive heart failure
AIDS
pregnancy, breastfeeding
no information could be given to the patient (subject faces emergency situation, comprehension difficulties, etc.)
patient under guardianship
patients under judicial protection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Outpatients followed at specialty clinics in HUS and at risk of NAFLD: with at least one metabolic risk factor (overweight, diabetes mellitus, hypertension, hypertriglyceridemia) and/or elevated transaminases and/or liver steatosis on US.

Sampling Method

Non-Probability Sample

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases