NCT05971108 Real-world Elecsys® GAAD Implementation and Validation to Improve Surveillance and Early Detection of HCC
| NCT ID | NCT05971108 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Manchester University NHS Foundation Trust |
| Condition | Liver Cirrhosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2030-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 600 participants in total. It began in 2024-01-08 with a primary completion date of 2030-07-31.
⚠ 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
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 Criteria
Inclusion Criteria: • Patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance Exclusion Criteria: * Pregnancy/breast-feeding. * Patients who do not have liver cirrhosis * Patients who already have hepatocellular carcinoma * Any patient who is unable to understand, retain and weigh information to make an informed decision, will be excluded from the study. The investigators will use every opportunity, including tele-interpretation services to minimise this from happening.
Contact & Investigator
Varinder Athwal, MRCP PhD
PRINCIPAL INVESTIGATOR
Manchester University NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT05971108 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05971108 currently recruiting?
Yes, NCT05971108 is actively recruiting participants. Contact the research team at varinder.athwal@mft.nhs.uk for enrollment information.
Where is the NCT05971108 trial being conducted?
This trial is being conducted at Manchester, United Kingdom.
Who is sponsoring the NCT05971108 clinical trial?
NCT05971108 is sponsored by Manchester University NHS Foundation Trust. The principal investigator is Varinder Athwal, MRCP PhD at Manchester University NHS Foundation Trust. The trial plans to enroll 600 participants.