Improving early detection of liver cancer in patients with cirrhosis
Real-world Elecsys® GAAD Algorithm Implementation and Validation to Improve Surveillance and Early Detection of Hepatocellular Carcinoma
NA · Manchester University NHS Foundation Trust · NCT05971108
This study is testing a new tool to see if it can help doctors find liver cancer earlier and more accurately in patients with cirrhosis who are already being monitored for it.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Manchester University NHS Foundation Trust (other gov) |
| Locations | 1 site (Manchester, Greater Manchester) |
| Trial ID | NCT05971108 on ClinicalTrials.gov |
What this trial studies
This study aims to implement the Elecsys® GAAD algorithm in real-world settings to enhance the surveillance and early detection of hepatocellular carcinoma (HCC) in patients with liver cirrhosis. Researchers will compare the effectiveness of Elecsys® GAAD against standard care tests to determine if it leads to earlier detection of HCC, reduces false positives, and improves patient adherence to surveillance protocols. The study focuses on patients already under HCC surveillance or referred for it due to their liver cirrhosis.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with known liver cirrhosis who are referred for or already undergoing hepatocellular carcinoma surveillance.
Not a fit: Patients who do not have liver cirrhosis or those who already have hepatocellular carcinoma will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve early detection rates of hepatocellular carcinoma, leading to better treatment options and outcomes for patients.
How similar studies have performed: While the specific implementation of Elecsys® GAAD is novel, similar approaches in enhancing cancer surveillance have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Manchester, Greater Manchester
- Manchester University NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Varinder Athwal, MRCP PhD — Manchester University NHS Foundation Trust
- Study coordinator: Varinder Athwal, PhD
- Email: varinder.athwal@mft.nhs.uk
- Phone: 0300 3309444
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.
Conditions: Liver Cirrhosis, Hepatocellular Carcinoma, GAAD, hepatocellular carcinoma, cirrhosis, health inequalities, surveillance