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Addition of GAAD score to imaging surveillance for early identification of liver cancer.

Addition of GAAD score to imaging surveillance for early identification of liver cancer. - ADRENALIN

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56668
Enrollment
1000
Registered
2024-03-05
Start date
2024-03-08
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma liver cancer.

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - All patients with cirrhosis - Non-cirrhotic chronic hepatitis B patients meeting any of the following criteria: positive family history for hepatocellular carcinoma, intermediate-high aMAP and/or (m)PAGE-B score (if non-Caucasian) - Non-cirrhotic chronic hepatitis C patients (with or without SVR) with a history of F3 fibrosis (based on histology or liver stiffness assessment) - Non-cirrhotic NASH patients with a history of F3 fibrosis (based on histology or liver stiffness assessment)

Exclusion criteria

Exclusion criteria: - Diagnosis with any other cancer other than non-melanoma skin cancer - History of hepatocellular carcinoma - Women who are pregnant or lactating - Patient with glomerular filtration rate

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy of the GAAD score (cut-off 2.57) for detection of HCC (overall and by BCLC stage), expressed using sensitivity, specificity, negative predictive value and positive predictive value.

Secondary

MeasureTime frame
nvt

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)