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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05971108
Other study ID # B01938
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 8, 2024
Est. completion date July 31, 2030

Study information

Verified date February 2024
Source Manchester University NHS Foundation Trust
Contact Varinder Athwal, PhD
Phone 0300 3309444
Email varinder.athwal@mft.nhs.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date July 31, 2030
Est. primary completion date July 31, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
Elecsys® GAAD
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.

Locations

Country Name City State
United Kingdom Manchester University NHS Foundation Trust Manchester Greater Manchester

Sponsors (5)

Lead Sponsor Collaborator
Manchester University NHS Foundation Trust Imperial College London, Roche Pharma AG, Unity Insights, University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of hepatocellular carcinoma diagnosis Incidence recorded as number of cases per study cohort 2 years
Primary Stage of hepatocellular carcinoma at diagnosis Barcelona Clinic Liver Cancer (BCLC) stage 0-D 2 years
Secondary 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:
Alpha-fetoprotein (AFP) vs GAAD
Ultrasound scan (USS) vs GAAD
AFP+ USS vs GAAD
AFP+USS vs GAAD +USS
AFP/GAAD/USS/AFP+USS/GAAD+USS vs MRI/CT for those who proceed to confirmatory imaging.
2 years
Secondary 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
Secondary Rates of adherence • Attendance rates for biannual surveillance appointments (%), within predefined tolerance of 5-9 months post previous appointment. 2 years
Secondary Rates of discontinuation • Count (%) of surveillance discontinuation, defined as no visit >12 months. 2 years
Secondary 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
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