SarcoidosisNCT02361281
Validation of a Non-invasive Diagnostic Method for Sarcoidosis Using Exhaled Breath
An observational study of Sarcoidosis, run by Maastricht University.
Trial summary
Sarcoidosis is a chronic lung disease that is characterized by fatigue, shortness of breath, chest pain and reduced lung function. Suffering from these diseases has a very negative effect on the quality of life. When people are suspected of having sarcoidosis various markers in the blood are measured. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sarcoidosis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: sarcoidosis patients with confirmed disease, with a range of disease stages. Average age for all study subjects: +- 50 y/o male/female ratio: approx 15 men vs. 10 women in each group.
Who may be able to join
- Patients with confirmed sarcoidosis
Who cannot join
- (ex-) smokers
- for healthy controls: controls with pulmonary disease excluded
About this study
Official title: Validation of a Previously Performed Study on Non-invasive Diagnostic Method for Sarcoidosis Using Exhaled Breath
Sarcoidosis is a chronic lung disease that is characterized by fatigue, shortness of breath, chest pain and reduced lung function. Suffering from these diseases has a very negative effect on the quality of life. When people are suspected of having sarcoidosis various markers in the blood are measured. Ultimate diagnosis, however, always requires invasive techniques such as bronchoscopy and lung biopsy. Consequently, there is an urgent need for a new diagnostic tool that is easy, quick and most of all non-invasive and thus friendly for the patient.
Such a new diagnostic tool might be found in examining the exhaled air of patients, which contains a complex mixture of so-called volatile organic compounds (VOCs) that are the result of damaging processes that occur in the lung. Determining the VOC profile in the breath can be used as a biomarker, or biological indicator, of those damaging processes. In other words, searching for unique VOC profiles in the breath of sarcoidosis patients might lead to the development of a diagnostic tool that only uses their exhaled breath.
The current study involves 25 sarcoidosis patients and 25 healthy volunteers. The aim of this study is find VOCs in exhaled air that can be used to diagnose sarcoidosis. In a previous study, sarcoidosis-specific VOCs were found, which we intend to validate using the current study.
- Conditions
- Sarcoidosis
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sarcoidosis patients | Clinically relevant sarcoidosis patients with different stages and treatments. | |
| Healthy controls | Healthy people without any pulmonary conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis by exhaled breath
Measured: upon regular visit to clinic, which is expected to occur on average within 4 months after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionMar 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Gelderse Vallei Hospital, Atrium Medical Center
- Responsible party
- Sponsor
- Investigators
- Rianne Fijten, MSc, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361281
- Sponsor's protocol ID
- BC/1408-389
- Status last verified
- Feb 2015
- First submitted
- 2 Feb 2015
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fijten RRR, Smolinska A, Drent M, Dallinga JW, Mostard R, Pachen DM, van Schooten FJ, Boots AW. The necessity of external validation in exhaled breath research: a case study of sarcoidosis. J Breath Res. 2017 Nov 29;12(1):016004. doi: 10.1088/1752-7163/aa8409.
PubMed 28775245
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Previously Performed Study on Non-invasive Diagnostic Method for Sarcoidosis Using Exhaled Breath
- ClinicalTrials.gov ID
- NCT02361281
- Acronym / sponsor ID
- BC/1408-389
- Conditions
- Sarcoidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Gelderse Vallei Hospital, Atrium Medical Center
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sarcoidosis is a chronic lung disease that is characterized by fatigue, shortness of breath, chest pain and reduced lung function. Suffering from these diseases has a very negative effect on the quality of life. When people are suspected of having sarcoidosis various markers in the blood are measured. Ultimate diagnosis, however, always requires invasive techniques such as bronchoscopy and lung biopsy. Consequently, there is an urgent need for a new diagnostic tool that is easy, quick and most of all non-invasive and thus friendly for the patient.
Such a new diagnostic tool might be found in examining the exhaled air of patients, which contains a complex mixture of so-called volatile organic compounds (VOCs) that are the result of damaging processes that occur in the lung. Determining the VOC profile in the breath can be used as a biomarker, or biological indicator, of those damaging processes. In other words, searching for unique VOC profiles in the breath of sarcoidosis patients might lead to the development of a diagnostic tool that only uses their exhaled breath.
The current study involves 25 sarcoidosis patients and 25 healthy volunteers. The aim of this study is find VOCs in exhaled air that can be used to diagnose sarcoidosis. In a previous study, sarcoidosis-specific VOCs were found, which we intend to validate using the current study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcoidosis patients | – | –Clinically relevant sarcoidosis patients with different stages and treatments. |
| Healthy controls | – | –Healthy people without any pulmonary conditions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- sarcoidosis patients with confirmed disease, with a range of disease stages. Average age for all study subjects: +- 50 y/o male/female ratio: approx 15 men vs. 10 women in each group.
Key inclusion criteria (1 listed)
- Patients with confirmed sarcoidosis
Key exclusion criteria (2 listed)
- (ex-) smokers
- for healthy controls: controls with pulmonary disease excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
diagnosis by exhaled breath
Time frame: upon regular visit to clinic, which is expected to occur on average within 4 months after the start of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
- Derived from this study: PubMed 28775245Fijten RRR, Smolinska A, Drent M, Dallinga JW, Mostard R, Pachen DM, van Schooten FJ, Boots AW. The necessity of external validation in exhaled breath research: a case study of sarcoidosis. J Breath Res. 2017 Nov 29;12(1):016004. doi: 10.1088/1752-7163/aa8409.
Related trials for Sarcoidosis
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Role of Genetic Factors in the Development of Lung Disease
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LAM-001 for the Treatment of Sarcoidosis Associated Pulmonary Hypertension (SAPH)
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A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
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An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
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Sarcoidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rianne Fijten, MSc principal investigator
Maastricht University
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, run by Maastricht University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis by exhaled breath (time frame: upon regular visit to clinic, which is expected to occur on average within 4 months after the start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02361281, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.