We hypothesize that an electronic nose can discriminate between the exhaled breath of patients with established pulmonary sarcoidosis from healthy controls Secondly, we hypothesize that an electronic nose can discriminate between different stages of…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Smellprint of sarcoidosis patients versus controls.
Smellprint of patients with different radiological stages.
Secondary outcome
Hypothesize that an electronic nose can discriminate between different stages
of pulmonary sarcoidosis (sub-phenotyping)
Finally we aim to characterize VOCs in samples detected by the electronic nose
by gas-chromatography and mass-spectrometry
Background summary
Sarcoidosis is a systemic granulomatous disease of unknown cause that affects
the lungs in over 90% of cases. On an epidemiological basis there is an
association between the radiological stages I-IV and the prognosis of the lung
involvement in terms of spontaneous resolution or persistent disease. However,
there is a considerable variability in the prognosis of individual patients
within these radiological phenotypes. There is no straightforward way to assess
disease activity and severity, so that predicting the course and prognosis in
individual cases is difficult. Decisions on whether or not to start treatment
often have to be taken on arbitrary grounds.
During the last few years the analysis of exhaled breath has been proposed as a
novel diagnostic tool for patients with a variety of lung diseases, including
those with chronic inflammation ENoses represent an innovative method of
sampling of volatile organic compounds (VOCs). They principally follow an
empirical approach, allowing the distinction of *smell-prints* obtained from
various gaseous sources by pattern recognition, providing discrimination of gas
mixtures irrespective of the individual molecular components. We have validated
this method and observed adequate discrimination between subjects with and
without asthma and patients with asthma and COPD.
We hypothesize that an electronic nose can discriminate between the exhaled
breath of patients with established pulmonary sarcoidosis from healthy
controls. In addition, we hypothesize that an electronic nose can discriminate
between different stages of pulmonary sarcoidosis (sub-phenotyping). Finally we
aim to characterize the VOCs in samples detected by the electronic nose by
gas-chromatography and mass-spectrometry.
Study objective
We hypothesize that an electronic nose can discriminate between the exhaled
breath of patients with established pulmonary sarcoidosis from healthy controls
Secondly, we hypothesize that an electronic nose can discriminate between
different stages of pulmonary sarcoidosis (sub-phenotyping)
Finally we aim to characterize VOCs in samples detected by the electronic nose
by gas-chromatography and mass-spectrometry
Study design
A case-control cross sectional study will be performed with a total number of
120 subjects. 60 patients and 60 controls.
Study burden and risks
Minimal burden, no risks.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Adult patients, between 18-70 years old, with a confirmed diagnosis of sarcoidosis. (Diagnosis of sarcoidosis according to the generally accepted consensus criteria.)
* Treatment naïve patients. A low dose oral prednisolone (< 10 mg daily) will be allowed.
Exclusion criteria
* Patients with underlying conditions with an established effect on the exhaled VOCs.
* Any other respiratory disease except sarcoidosis and/or any systemic diseases.
* Respiratory tract infections requiring antibiotics and/or oral steroids in the 4 weeks prior to the study will be excluded.
* Current and ex tobacco Smoking. (However, patients with a smoking history of < 1 packyear and no smoking during the past 10 years can be included).
* Prior diagnosis of malignancies
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 | NL31952.018.10 |