The purpose of the registry is to determine disease development of advanced and non-advanced sarcoidosis. In addition, the registry would note the other organ involvemen, treatment and quality of life.
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disease development of advanced and non-advanced sarcoidosis.
Secondary outcome
Quality of life for patients with advanced and non-advanced sarcoidosis as
assessed using questionairs
Background summary
A. Specific Aims: During the past 20 years, new treatments have been developed
for sarcoidosis. Many of these treatments have been directed towards patients
with advanced disease. However, the natural course of patients with advanced
and non-advanced disease is not knoen. The purpose of the registry is to
determine the development of sarcoidosis. In addition, the registry would note
the other organ involvement and treatment used for these patients and the
quality of life of patients.
B. Background and significance: The clinical outcome of sarcoidosis is
variable. While over half of patients have resolution of their disease within
two years of diagnosis, at least a quarter of patients will have chronic
disease requiring therapy for more than five years. Certain manifestations of
sarcoidosis are associated with chronic disease. These include pulmonary
fibrosis, neurologic and cardiac disease, lupus pernio, and those requiring
treatment.
The use of potent agents such as infliximab have proved useful in treating
advanced sarcoidosis. This treatment regimen is associated with significant
cost and requires careful monitoring. Other potent agents have also been used
for advanced sarcoidosis, including adalimumab, rituximab, cyclophosphamide,
and Acthar. This registry will determine diseae development in advanced and
non-advanced patients, organ involvement, use of medication and quality of life
via questionairs.
Study objective
The purpose of the registry is to determine disease development of advanced and
non-advanced sarcoidosis. In addition, the registry would note the other organ
involvemen, treatment and quality of life.
Study design
Observational study
Study burden and risks
The completion of the questionnaires may be time consuming but no other risks.
There are no risks associated with participation. By being a subject in this
study, a patient helps to gain insight in the clinical course of sarcoidosis.
In time, this may improve the treatment of patients with sarcoidosis.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
* Patients with diagnosis of sarcoidosis based on ATS/WASOG criteria 22
* Age * 18 years.
* Life expectancy of at least 2 years.
* Pulmonary function tests (spirometry) within one month of entry or willing to under pulmonary
function testing on the day of study enrollment
* Sarcoidosis as characterized as either advanced or non-advanced (see protocol for definition
of advanced disease)
* Subjects must be able to understand and be willing to sign the written informed consent
form. A signed informed consent form must be appropriately obtained prior to the conduct of
any trial-specific procedure.
Exclusion criteria
* Subjects with a medical disorder, condition, or history of such that would impair the subject*s
ability to participate or complete this study in the opinion of the investigator
* Inability to comply with the protocol and/or not willing or not available for follow-up
assessments.
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 | NL60192.100.17 |