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Epidemiology and natural history of and risk factors for primary sclerosing cholangitis & primary biliary cirrhosis in the Netherlands

Epidemiology and natural history of and risk factors for primary sclerosing cholangitis & primary biliary cirrhosis in the Netherlands - Epidemiology of PSC/PBC

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47329
Enrollment
1100
Registered
2007-04-17
Start date
2007-12-08
Completion date
Unknown
Last updated
2024-06-18

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

Conditions

Chronic cholestatic liver disease

Interventions

None listed

Sponsors

1. Amsterdams Gastroenterologisch Genootschap, 2. Stichts Genootschap, 3. Duamutef
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Established diagnosis of PSC Established diagnosis of PBC age > 18. Resident in the Netherlands.

Exclusion criteria

Exclusion criteria: Inability to give informed consent

Design outcomes

Primary

MeasureTime frame
Primary endpoints: True population-based point-prevalence (2006) and inferred incidence of newly diagnosed cases (2000-2006); natural history with respect to death, liver transplantation, occurrence of cholangiocarcinoma and colorectal carcinoma.

Secondary

MeasureTime frame
Secondary endpoints: Odds ratio and relative risk determination of several putative environmental, behavioural and genetic risk factors between PSC and PBC as well as control groups. Among these are smoking behaviuor, previous appendectomy, familial occurrence, previous Chlamydia infection, CCL25 polymorphisms, and the protective effect on the natural history of immunomodulatory medication.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)