Nonalcoholic Fatty Liver DiseaseNASH-SPENCT04282447
Screening of NASH in Oupatients Followed in Various Hospital Specialty Clinics at the University Hospital of Strasbourg
An observational study of Nonalcoholic Fatty Liver Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 14 Aug 2020to May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Lawrence SERFATY, +33 3 88 12 88 02, Lawrence.serfaty@chru-strasbourg.fr
Laurence SERFATY
About this study
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.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated prevalence of NASH with advanced fibrosis among several hospital specialty clinics
To assess the estimated prevalence of NASH , calcul of the FIB4
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start14 Aug 2020
- Primary completion14 Aug 2020
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282447
- Sponsor's protocol ID
- 7376
- Acronym
- NASH-SPE
- Status last verified
- Feb 2020
- First submitted
- 21 Feb 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of NASH in Oupatients Followed in Various Hospital Specialty Clinics at the University Hospital of Strasbourg
- ClinicalTrials.gov ID
- NCT04282447
- Acronym / sponsor ID
- NASH-SPE / 7376
- Conditions
- Nonalcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- May 2022 (estimated)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimated prevalence of NASH with advanced fibrosis among several hospital specialty clinics
Time frame: 3 months
To assess the estimated prevalence of NASH , calcul of the FIB4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonalcoholic Fatty Liver Disease, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated prevalence of NASH with advanced fibrosis among several hospital specialty clinics (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020; AzTrials last refreshed its copy on 8 Nov 2026.