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

Sarcoidosis Clinical Trial

Official title:

Validation of a Previously Performed Study on Non-invasive Diagnostic Method for Sarcoidosis Using Exhaled Breath

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02361281
• Other study ID #: BC/1408-389
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 2, 2015
• Last updated: February 6, 2015
• Start date: December 2014
• Est. completion date: July 2015

Study information

• Verified date: February 2015
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: July 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with confirmed sarcoidosis

Exclusion Criteria:

• (ex-) smokers

• for healthy controls: controls with pulmonary disease excluded

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Sarcoidosis

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University	Atrium Medical Center, Gelderse Vallei Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No