NAFLDNAFLD CohortNCT07051863
Prospective Cohort and Biobank of Patients With Nonalcoholic Fatty Liver Disease
An observational study of NAFLD and MASH, run by Fondazione Epatocentro Ticino at 1 site in Switzerland.
Trial summary
The goal of this observational study is to establish a unified cohort for retrospective and prospective high quality baseline and follow-up data registration of patients with a diagnosis of NAFLD/NASH/MAFLD, according to standardized criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Jul 2023to Dec 2030
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patient wiht diagnosis of NAFLD/NASH/MAFLD
Who may be able to join
- Participant must be ≥ 18 years of age at the time of signing the informed consent
- Participant willing to sign the informed consent form (ICF) and to complete all study-specific procedures and visits
- To have a diagnosis of NAFLD/NASH/MAFLD followed at Epatocentro Ticino and collaborating/referring clinicians based on:
- Liver biopsy with a histological evidence of NAFLD/NASH/MAFLD OR
- Liver imaging (ultrasound, CT scan, MRI, CAP Controlled Attenuation Parameter) OR
- Diagnosis of metabolic syndrome and liver fibrosis or cirrhosis without an alternative diagnosis; metabolic syndrome fulfilling one or more of the below mentioned conditions:
Show all 12Show fewer
- Abdominal obesity: a waist circumference of more than 35 inches (>89cm) for women and more than 40 inches (>102 cm) for men;
- High blood pressure of 130/80 mm Hg or higher. Normal blood pressure is defined as less than 130 mm Hg for systolic pressure, and less than 80 mm Hg for diastolic pressure
- Impaired fasting blood glucose. This means a level equal to or greater than 100 mg/dL (>5.6 mmol/L)
- High triglyceride levels of more than 150 mg/dL (> 1.7mmol/L).
- Low HDL (good) cholesterol: less than 40 mg/dL (< 1.04 mmol/L) for men and less than 50 mg/dL (< 1.29 mmol/L) for women
- alcohol consumption less than 21 (males) or 14 (women) units per week in the 6 months before the enrolment and no history of excessive alcohol consumption in the 5 years before enrolment. One unit is 12g (grams) of pure alcohol; 10-12 grams of pure alcohol are contained in a 280-330 ml of beer, 150-180 ml of champagne, 30-40 ml of whisky or high-strength spirit, 60-80 ml of liqueur, and 100-120 ml of red wine
Who cannot join
- To have a diagnosis of type I diabetes mellitus
- To have a concomitant liver disease
- To take or have taken in the last 12 months before enrolment, on more than 50% of days, drugs that may cause liver steatosis (long-term high dose systemic corticosteroids (> 20mg prednisone equivalent), amiodarone, methotrexate, tamoxifen, tetracycline, high dose estrogens and valproic acid)
- Pregnancy and breast feeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maurizia Bissig contact
Switzerland1 site, 1 recruiting
- Recruiting
Fondazione Epatocentro Ticino
Lugano, Canton Ticino, 6900
Andreas Cerny, Prof. Dr. med, 0041919106570, andreas.cerny@hin.ch
Maurizia Bissig, maurizia.bissig@hin.ch
About this study
Official title: Prospective Cohort and Biobank of Patients With Nonalcoholic Fatty Liver Disease (NAFLD Cohort Study)
The goal of this observational study is to establish a unified cohort for retrospective and prospective high quality baseline and follow-up data registration of patients with a diagnosis of NAFLD/NASH/MAFLD, according to standardized criteria.
This will allow future studies aimed at elucidate clinical presentation, natural history, response to treatment, genetic and metabolic risk factors, treatment options and outcomes of the disease. The cohort will allow investigators to carry out genetic, serological, microbiologic and immunological studies.
- Keywords
- NAFLD, MASH, NASH, Steatoepatitis
- 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.
Establish a unified cohort for retrospective and prospective data of patients with a diagnosis of NAFLD/NASH/MAFLD
The primary objective of this project is to establish a unified cohort for retrospective and prospective highquality baseline and follow-up data registration of patients with a diagnosis of NAFLD/NASH/MAFLD, according to standardized criteria.
This will allow future studies aimed at elucidate clinical presentation, natural history, response to treatment, genetic and metabolic risk factors, treatment options and outcomes of the disease. The cohort will allow investigators to carry out genetic, serological, microbiologic and immunological studies.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start19 Jul 2023
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fondazione Epatocentro Ticino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051863
- Sponsor's protocol ID
- NAFLD Cohort Study
- Acronym
- NAFLD Cohort
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort and Biobank of Patients With Nonalcoholic Fatty Liver Disease (NAFLD Cohort Study)
- ClinicalTrials.gov ID
- NCT07051863
- Acronym / sponsor ID
- NAFLD Cohort / NAFLD Cohort Study
- Keywords
- NAFLD, MASH, NASH, Steatoepatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione Epatocentro TicinoUniversity, hospital or other
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Jul 2025 (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 goal of this observational study is to establish a unified cohort for retrospective and prospective high quality baseline and follow-up data registration of patients with a diagnosis of NAFLD/NASH/MAFLD, according to standardized criteria.
This will allow future studies aimed at elucidate clinical presentation, natural history, response to treatment, genetic and metabolic risk factors, treatment options and outcomes of the disease. The cohort will allow investigators to carry out genetic, serological, microbiologic and immunological studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient wiht diagnosis of NAFLD/NASH/MAFLD
Key inclusion criteria (12 listed)
- Participant must be ≥ 18 years of age at the time of signing the informed consent
- Participant willing to sign the informed consent form (ICF) and to complete all study-specific procedures and visits
- To have a diagnosis of NAFLD/NASH/MAFLD followed at Epatocentro Ticino and collaborating/referring clinicians based on:
- alcohol consumption less than 21 (males) or 14 (women) units per week in the 6 months before the enrolment and no history of excessive alcohol consumption in the 5 years before enrolment. One unit is 12g (grams) of pure alcohol; 10-12 grams of pure alcohol are contained in a 280-330 ml of beer, 150-180 ml of champagne, 30-40 ml of whisky or high-strength spirit, 60-80 ml of liqueur, and 100-120 ml of red wine
Key exclusion criteria (4 listed)
- To have a diagnosis of type I diabetes mellitus
- To have a concomitant liver disease
- To take or have taken in the last 12 months before enrolment, on more than 50% of days, drugs that may cause liver steatosis (long-term high dose systemic corticosteroids (> 20mg prednisone equivalent), amiodarone, methotrexate, tamoxifen, tetracycline, high dose estrogens and valproic acid)
- Pregnancy and breast feeding.
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
Establish a unified cohort for retrospective and prospective data of patients with a diagnosis of NAFLD/NASH/MAFLD
Time frame: 7 years
The primary objective of this project is to establish a unified cohort for retrospective and prospective highquality baseline and follow-up data registration of patients with a diagnosis of NAFLD/NASH/MAFLD, according to standardized criteria. This will allow future studies aimed at elucidate clinical presentation, natural history, response to treatment, genetic and metabolic risk factors, treatment options and outcomes of the disease. The cohort will allow investigators to carry out genetic, serological, microbiologic and immunological studies.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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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.
Maurizia Bissig contact
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 NAFLD and MASH, run by Fondazione Epatocentro Ticino at 1 site in Switzerland.
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 12 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Cerny, Prof. Dr. med (0041919106570, andreas.cerny@hin.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish a unified cohort for retrospective and prospective data of patients with a diagnosis of NAFLD/NASH/MAFLD (time frame: 7 years). 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 21 Jul 2026.