Optimizing Noninvasive assessMent Of DysmEtabolic Compensated Advanced Liver Disease

NCT06888310 | Recruiting

• 1 other identifier: 6843
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) is responsible for a significant proportion of liver-related deaths and healthcare costs in the United States, accounting for approximately 36% of liver-related deaths and over one billion dollars in annual healthcare expenses. \[PMID: 34863359\] A recent analysis of healthcare costs in Italy showed that out of the 9,729 NAFLD/NASH patients who were hospitalized and analyzed, the vast majority (97%) did not have advanced liver disease, while 1.3% had compensated advanced liver disease (cACLD), 3.1% had decompensated cirrhosis, 0.8% had hepatocellular carcinoma, and 0.1% underwent liver transplantation. The burden of comorbidities was high across all patient cohorts, and patients with cACLD required a greater number of inpatient services, outpatient visits, and the pharmacy fills compared to those without advanced liver disease. As disease severity increased, mean total annual costs also increased primarily due to higher inpatient services costs. In Italy, as in other EU countries, most of the healthcare costs for patients were attributed to NAFLD/NASH-related liver complications. Thus, the optimization of the non-invasive diagnosis of cACLD represents an urgent need in dysmetabolic liver disease. These advancements will play a crucial role in early detection, risk stratification, and effective management of highly prevalent liver diseases such as NAFLD/NASH and their progression.

Conditions

NASH; NAFLD

Outcome Measures

Primary Outcomes (1)

• number of patients identified with single diagnostic method

  evaluate the efficacy of risk-stratification pathways for cACLD detection and outcome prediction in adults (age\>18 years) with dysmetabolic liver disease in a tertiary care setting.

  24 months

Secondary Outcomes (1)

• number of patients identified with innovative diagnostic method omic-based

  24 months

Study Arms (1)

patients with MASLD and LSM>=10kPa

EXPERIMENTAL

To set an interventional prospective, cohort study where individuals will have a liver health check to identify cACLD. We will exclude subjects with decompensation (ascites, encephalopathy, gastrointestinal bleeding, or in case of the presence of transjugular intrahepatic portosystemic shunt). We aim to recruit a prospective cohort and randomize after the end of the study to derivation (2/3) and validation cohort (1/3). The cohort will be stratified according to the presence of Type 2 diabetes (T2D) and obesity (BMI\>= 30Kg/m2).

Procedure: extra blood sampling

Interventions

extra blood sampling PROCEDURE

search for biomarkers for the prevention of liver disease

patients with MASLD and LSM>=10kPa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age\>=18; sex (M,F);
• dysmetabolic liver disease according new nomenclature definition;
• suspicion of cACLD by LSM\>=10 with VCTE;
• routine esogastroduodenoscopy report within 12 months of VCTE for identification of high-risk varices (HRV).

You may not qualify if:

• portal vein thrombosis,
• infiltrative liver neoplasms, and conditions are known for their potential influence on the LSM results (congestive liver disease, extrahepatic biliary obstruction, ALT \> 5x upper normal limit).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Medicina Interna e Trapianto di Fegato

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Luca Miele

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Miele

CONTACT

+390630157717; luca.miele@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of UOS Pre Liver Trasplant

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: March 21, 2025
• Study Start: December 6, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

IT (1)