NCT06888310 Optimizing Noninvasive assessMent Of DysmEtabolic Compensated Advanced Liver Disease
| NCT ID | NCT06888310 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | NASH |
| Study Type | INTERVENTIONAL |
| Enrollment | 408 participants |
| Start Date | 2024-12-06 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 408 participants in total. It began in 2024-12-06 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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).
Contact & Investigator
Luca Miele
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06888310 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NASH. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06888310 currently recruiting?
Yes, NCT06888310 is actively recruiting participants. Contact the research team at luca.miele@policlinicogemelli.it for enrollment information.
Where is the NCT06888310 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06888310 clinical trial?
NCT06888310 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Luca Miele at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 408 participants.