Validation of a Non-invasive Diagnostic Method for Sarcoidosis Using Exhaled Breath

• Conditions: Sarcoidosis

• Registration Number: NCT02361281
• Lead Sponsor: Maastricht University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Status Verified: 2015-02
• Study First Submitted: 2015-02-02
• Study First Submitted QC: 2015-02-06
• Last Update Submitted: 2015-02-06
• Study First Posted: 2015-02-11
• Last Update Posted: 2015-02-11
• Primary Completion: 2015-03
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with confirmed sarcoidosis

Exclusion Criteria

• (ex-) smokers
• for healthy controls: controls with pulmonary disease excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
diagnosis by exhaled breath	upon regular visit to clinic, which is expected to occur on average within 4 months after the start of the study