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| Name | Class |
|---|---|
| University of Manchester | OTHER |
| Roche Pharma AG | INDUSTRY |
| Unity Insights | UNKNOWN |
| Imperial College London |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with liver cirrhosis eligible for HCC Surveillance | Experimental | Real-world HCC surveillance cohort will be exposed to Elecsys® GAAD in parallel with standard of care tests. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elecsys® GAAD | Diagnostic Test | Elecsys® GAAD is a CE marked in vitro diagnostic (IVD) multivariate index assay, intended as an aid in the diagnosis of early-stage HCC. It provides a semi quantitative result by combining in an algorithm the quantitative measurements of Elecsys® AFP (alpha-fetoprotein) and Elecsys® PIVKA-II (protein induced by vitamin K absence II) levels in serum and plasma, with gender and age. Clinical evidence showed that Elecsys® GAAD had high performance in detecting HCC (sensitivity 86.5%), particularly early stage (sensitivity 78.9%), with 91.4% specificity for both early and all stages, out-performing current standard of care (Chan et al. 2021). Elecsys® GAAD may be integrated into current surveillance practice to increase early-stage HCC detection rate, reduce unnecessary onward investigations and patient anxiety. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hepatocellular carcinoma diagnosis | Incidence recorded as number of cases per study cohort | 2 years |
| Stage of hepatocellular carcinoma at diagnosis | Barcelona Clinic Liver Cancer (BCLC) stage 0-D | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of false positives for each combination of diagnostic tests | Count (%) of True/False positives for each test (against magnetic resonance imaging (MRI) / computerised tomography (CT)) will be reported. Results from different tests (and their (meaningful) combination) will be tabulated against each other:
|
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Inclusion Criteria:
• Patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance
Exclusion Criteria:
Biological sex used in diagnostic algorithm
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Varinder Athwal, PhD | Contact | 0300 3309444 | varinder.athwal@mft.nhs.uk | |
| Christopher Mysko, MClinEd MRCP | Contact | 0300 3309444 | christopher.mysko@mft.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Varinder Athwal, MRCP PhD | Manchester University NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manchester University NHS Foundation Trust | Recruiting | Manchester | Greater Manchester | M13 9WL | United Kingdom |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006528 | Carcinoma, Hepatocellular |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
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|
| 2 years |
| Rates of curative treatment | Rates of curative treatment being offered (%) will be recorded on an intention to treat (ITT) basis from Multi-Disciplinary Team (MDT) meeting outcomes. | 2 years |
| Rates of adherence | • Attendance rates for biannual surveillance appointments (%), within predefined tolerance of 5-9 months post previous appointment. | 2 years |
| Rates of discontinuation | • Count (%) of surveillance discontinuation, defined as no visit >12 months. | 2 years |
| Survival rates | Long-term follow up data will be collected to determine rates of survival following HCC diagnosis at 1-year, 3-years and 5-years. | 7 years |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |