Main objectives: To obtain true population-based prevalence and incidence figures, as well as insight in the natural history of PSC and PBC in The Netherlands.Secondary objectives: to determine risk factors correlated with PSC and PBC respectively,…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Primary sclerosing cholangitis (PSC) and primary biliary cirrhosis (PBC) are
relatively rare liver diseases that in most cases lead to liver failure in
10-20 year. Nowadays, both diseases are regarded as immune dysbalance disease
entities, but in fact the aetiology is unknown.
Regarding the prevalence, incidence and natural history of PSC and PBC there
are only crude estimates. True population-based studies have not been carried
out.
Study objective
Main objectives: To obtain true population-based prevalence and incidence
figures, as well as insight in the natural history of PSC and PBC in The
Netherlands.
Secondary objectives: to determine risk factors correlated with PSC and PBC
respectively, such as environmental factors, behavioural factors and genetic
factors; to build two large inception cohorts of PSC and PBC patients for
future studies.
Study design
Observational longitudinal cohort study with case-control substudies.
In all hospitals of the Gut-club-, Stichts Genootschap-, and Duamutef Society
members all PSC and PBC patients will be traced via several independent local
search strategies. Charts will be reviewed for relevant data. Follow-up data
will be collected by yearly correspondence.
Study burden and risks
Burden with participation consists of filling in a single leaflet 9-item
questionnaire and drawing of two extra blood samples during routine outpatient
blood testing. No extra visits are scheduled (only for patients included before
2013).
Periodic digital questionnaires.
p/a v Eeghenstraat 115
Amsterdam 1071 GA
NL
p/a v Eeghenstraat 115
Amsterdam 1071 GA
NL
Listed location countries
Age
Inclusion criteria
Established diagnosis of PSC
Established diagnosis of PBC
age > 18.
Resident in the Netherlands.
Exclusion criteria
Inability to give informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14614.041.06 |