Real-world Elecsys® GAAD Algorithm Implementation and Validation to Improve Surveillance and Early Detection of Hepatocellular Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• • Patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance

Locations
Other Locations
United Kingdom
Manchester University NHS Foundation Trust
RECRUITING
Manchester
Contact Information
Primary
Varinder Athwal, PhD
varinder.athwal@mft.nhs.uk
0300 3309444
Backup
Christopher Mysko, MClinEd MRCP
christopher.mysko@mft.nhs.uk
0300 3309444
Time Frame
Start Date: 2024-01-08
Estimated Completion Date: 2030-07-31
Participants
Target number of participants: 600
Treatments
Experimental: Patients with liver cirrhosis eligible for HCC Surveillance
Real-world HCC surveillance cohort will be exposed to Elecsys® GAAD in parallel with standard of care tests.
Related Therapeutic Areas
Sponsors
Collaborators: Unity Insights, Imperial College London, Roche Pharma AG, University of Manchester
Leads: Manchester University NHS Foundation Trust

This content was sourced from clinicaltrials.gov