NCT07502755Active, not recruiting
Non-invasive Tests for Non-alcoholic Steato-hepatitis
Non-invasive Blood Tests for the Diagnosis and Therapeutic Monitoring of Non-alcoholic Steato-hepatitis
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
The main objective is to study and validate a new approach for NASH and liver fibrosis diagnosis and personalized follow-up based on monocyte biomarkers and plasma metabolites. The investigators will assess if PLIN2 and RAB14 can be used not only to identify subjects with NASH and advanced fibrosis but also for monitoring the effect of treatment alone or in combination with other metabolic parameters
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 828 (estimated)
- First submitted
- 18 Jul 2024
- Start date
- 31 Aug 2024
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07502755
What you commit to
- Study type: Interventional
- Planned participants: 828
- From 31 Aug 2024 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- All units: Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 6 months; Liver cirrhosis; End stage renal failure; Participation in any other concurrent therapeutic clinical trial; Any other life-threatening, non-cardiac disease; Pregnancy; Inability to give informed consent; Substantial alcohol consumption (\>20 g/day for women or \>30 g/day for men); Wilson's disease; Lipodystrophy; Parenteral nutrition; Abetalipoproteinemia; Interfering medications (e.g., amiodarone, methotrexate, tamoxifen, corticosteroids).
Who the study is looking for
- Policlinico Universitario Agostino Gemelli IRCCS: Subjects with NASH documented by liver biopsy or fibroscan and no evidence of another form of liver disease with a BMI ≥ 30 and ≤40 kg/m2. Age 25-65 years.
- Coorte Azienda Ospedaliera Mater Domini: subjects with NASH documented by liver fibroscan aged \>40 years with one or more cardiovascular risk factors,including overweight/obesity, elevated blood pressure, dyslipidemia, and dysglycemia
- Azienda Ospedaliero-Universitaria Policlinico Federico II: Subjects with NASH documented by fibroscan and no evidence of another form of liver disease. Age 25-65 years.
Age in the registry: 25 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.