To determine the prevalence of mycobacterial, propionibacterial and beryllium, aluminium and zirconium sensitized patients within a well-defined Dutch cohort of biopsy proven sarcoidosis patients.New clinico-pathological phenotypes within the group…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the prevalence of sensitization against mycobacteria,
propionibacteria and metals including beryllium, aluminium and zirconium in
sarcoidosis patients
Secondary outcome
Compare the classical lymphocyte proliferation test with the interferon gamma
release assay
Background summary
Sarcoidosis is a systemic disorder of unknown etiology. The majority of
patients is between 20 and 40 years of age. In general the disease has a
favourable course, with spontaneous remission in 70% of patients within 3 years
from diagnosis. In the remaining group of patients, the disease can become
chronic, and will be fatal in approximately 5% of patients. An important
characteristic of the disease are non-caseating granulomas. So far, the cause
of the disease is unknown. Many potential organic/anorganic substances or
microorganisms have been suggested to trigger sarcoidosis such as aluminium,
beryllium, zirconium, mycobacteria and propionibacteria.
Long term exposure to beryllium can cause berylliosis, which is difficult to
distinguish from sarcoidosis. It has already been demonstrated in several
studies that some berylliosis patients were initial incorrectly diagnosed with
sarcoidosis. An interesting hypothesis might be that berylliosis is a type of
sarcoidosis in which the inducing antigen is known. The estimated mortality of
berylliosis is 25%, which is far higher compared to sarcoidosis. In The
Netherlands, no information is available about the eventual prevalence of
berylliosis among the group of sarcoidosis patients.
Currently, no curative treatment is available for sarcoidosis. Routine testing
for possible triggers in sarcoidosis is not daily clinical practice. However,
published data suggest that possible triggers could be identified in 74% of
patients. Conformation of these data in Dutch patients can lead the way for
randomized controlled trials in distinct subgroups of patients assessing the
efficacy of antimycobacterial or antipropionbacterial treatment. If
sensitization for metals in sarcoidosis patients can be determined, avoiding
exposure is an important extra therapeutic option in treating their disease.
Study objective
To determine the prevalence of mycobacterial, propionibacterial and beryllium,
aluminium and zirconium sensitized patients within a well-defined Dutch cohort
of biopsy proven sarcoidosis patients.
New clinico-pathological phenotypes within the group of sarcoidosis patients
will be defined, using the data on sensitization in combination with a 4 year
follow up in order to define the Clinical Outcome Score (COS) after 2 and 4
years of follow up.
In addition, a comparison will be made between the classic lymphocyte
proliferation test and interferon gamma release assay in detecting metal
sensitization
Study design
Retrospective and prospective cohort study
Study burden and risks
Burden and risks are minimal due to the fact that vein puncture is the only
invasive proceidure during the study.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
Biopsy proven diagnosis of Sarcoidosis
Exclusion criteria
none
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 | NL49563.100.14 |