Improving noninvasive assessment of advanced liver disease
Optimizing Noninvasive assessMent Of DysmEtabolic Compensated Advanced Liver Disease by Integration of Artificial Intelligence Model and omicS Data
NA · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06888310
This study is trying to find better ways to diagnose advanced liver disease in people with non-alcoholic fatty liver disease to help improve their treatment and care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 408 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Roma) |
| Trial ID | NCT06888310 on ClinicalTrials.gov |
What this trial studies
This study focuses on enhancing diagnostic methods for compensated advanced liver disease (cACLD) caused by metabolic dysfunction, particularly in patients with non-alcoholic fatty liver disease (NAFLD). By utilizing advanced technologies such as radiomics, digital pathology, and artificial intelligence, the research aims to create a comprehensive database that can improve the stratification and management of cACLD. The study will involve extra blood sampling and aims to provide novel insights that could lead to better patient outcomes and more efficient healthcare resource utilization.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with dysmetabolic liver disease and a suspicion of compensated advanced liver disease.
Not a fit: Patients with conditions such as portal vein thrombosis or infiltrative liver neoplasms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and management of patients with advanced liver disease, ultimately enhancing patient care.
How similar studies have performed: While the integration of AI and advanced diagnostic techniques is a growing field, this specific approach to cACLD is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Roma
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Medicina Interna e Trapianto di Fegato — Roma, Italy (RECRUITING)
Study contacts
- Principal investigator: Luca Miele — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Luca Miele
- Email: luca.miele@policlinicogemelli.it
- Phone: +390630157717
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.