Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT07249112
Eligibility Criteria:
Inclusion Criteria:
Specific Inclusion Criteria for Patients with Advanced MASLD:
* Patients with advanced MASLD defined as liver fibrosis ≥2 and/or the development of HCC (Hepatocellular Carcinoma);
* Patients enrolled in the context of the SERENA study and, where applicable, also in the context of the REASON study;
* Liver biopsy for suspected Non-Alcoholic Steatohepatitis (NASH) at the time of diagnosis;
* Cholecystectomies;
* Age \[40-70 years\];
* Patients who have signed the informed consent form.
Specific Inclusion Criteria for the Control Group:
Blood donors participating in the Liver Bible study aged between 40 and 70 years who are overweight or obese and have at least two of the following risk factors:
* Impaired fasting glucose or Diabetes Mellitus
* Dyslipidemia
* Arterial hypertension.
Exclusion Criteria:
Specific exclusion Criteria for Patients with Advanced MASLD:
* Positivity for chronic viral hepatitis (HCV-RNA and/or HBsAg);
* Positivity for other liver diseases such as autoimmune and viral hepatitis (Hepatitis B and C), hereditary hemochromatosis, alpha-1-antitrypsin deficiency, or Wilson's disease.
Specific Exclusion Criteria for the Control Group:
Subjects with chronic degenerative diseases will be excluded, with the exception of well-controlled hypertension and Type 2 Diabetes Mellitus that does not require pharmacological therapy (as is already standard practice for blood donation eligibility). Also excluded are donors aged \> 65 and \< 40 years.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT07249112
Study Brief:
Protocol Section:
NCT07249112