Phase 4Completed
Real-world Elecsys® GAAD Implementation and Validation to Improve Surveillance and Early Detection of HCC (REVISE-HCC)
Real-world Elecsys® GAAD Algorithm Implementation and Validation to Improve Surveillance and Early Detection of Hepatocellular Carcinoma
- Sponsor
- Manchester University NHS Foundation Trust (Government)
- Enrolment
- 657 enrolled
- Conditions
- Liver Cirrhosis; Hepatocellular Carcinoma
- Interventions
- Elecsys® GAAD
- Ages
- adults, older adults
- Registry
- NCT05971108
Full record on ClinicalTrials.gov
From the registry
Patients with liver cirrhosis are at high risk of developing hepatocellular carcinoma (HCC) which implies significant mortality. At present current surveillance methods detect hepatocellular carcinomas at a late stage resulting in few treatment options for patients and, in the majority of cases, premature death. The goal of this study is to implement Elecsys® GAAD in real-world hepatocellular carcinoma surveillance for those with liver cirrhosis. The main questions it aims to answer are: * Does the introduction of the Elecsys® GAAD algorithm to the surveillance pathway increase early detection of HCC? * Does the introduction of the Elecsys® GAAD algorithm to the surveillance pathway reduce false positive tests and unnecessary confirmatory investigations? * Does the new surveillance pathway improve adherence? Researchers will compare Elecsys® GAAD with standard of care tests to see if it results in earlier detection of hepatocellular carcinoma and will explore potential improvements to the surveillance pathway.
Primary outcomes
- Incidence of hepatocellular carcinoma diagnosis
- Stage of hepatocellular carcinoma at diagnosis
History
Last registry update
Primary completion
Started
Registered