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SEAL - Structured Early Assessment of Asymptomatic Liver Fibrosis and Cirrhosis

SEAL - Structured Early Assessment of Asymptomatic Liver Fibrosis and Cirrhosis - SEAL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00013460
Enrollment
15855
Registered
2018-01-04
Start date
2018-03-26
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

K74.0 K74.1 K74.2 K74.3 K74.4 K74.5 K74.6 K70.2 K70.3 K71.7

Interventions

Group 1: Study participants are being screened for elevated liver enzymes ALT and AST. If ALT and/or AST are elevated, liver fibrosis risk is estimated using the AST-/platelet ratio index (APRI). Part

Sponsors

UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to No maximum

Inclusion criteria

Inclusion criteria: - Member of the statutory health insurer AOK Rhineland-Palatinate/Saarland - Age = 35 years - Eligible for check-up 35 health check - Informed consent

Exclusion criteria

Exclusion criteria: - Not able to give informed consent - Pregnancy

Design outcomes

Primary

MeasureTime frame
Primary objective is the number of diagnosis of relevant liver fibrosis or liver cirrhosis by using the SEAL-algorithm per 10.000 check-up 35 health checks in comparison with 10.000 historical check-up 35 health checks.

Secondary

MeasureTime frame
Secondary objectives: - prevalence of liver enzyme elevation in the general population - prevalence of chronic liver disease in the general population - number needed to screen - estimation of cost of liver screening - complications and costs within the initial 3 and 12 months after diagnosis of liver fibrosis and cirrhosis by using the SEAL-algorithm compared to patients diagnosed without liver screening - estimation of costs saved by early diagnosis

Countries

Germany

Contacts

Public ContactAnita Arslanow

UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität MainzI. Medizinische Klinik und Poliklinik

anita.arslanow@uni-mainz.de+49 6131 17-2844

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 18, 2026