Validation of a Non-invasive Diagnostic Method for Sarcoidosis Using Exhaled Breath
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02361281|
Recruitment Status : Unknown
Verified February 2015 by Maastricht University.
Recruitment status was: Enrolling by invitation
First Posted : February 11, 2015
Last Update Posted : February 11, 2015
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Observational Model:||Case Control|
|Official Title:||Validation of a Previously Performed Study on Non-invasive Diagnostic Method for Sarcoidosis Using Exhaled Breath|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||July 2015|
Clinically relevant sarcoidosis patients with different stages and treatments.
Healthy people without any pulmonary conditions
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361281
|Principal Investigator:||Rianne Fijten, MSc||Maastricht University|