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

NCT ID: NCT02361281

Last Updated: 2015-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-07-31

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.

Conditions

Sarcoidosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Sarcoidosis patients

Clinically relevant sarcoidosis patients with different stages and treatments.

No interventions assigned to this group

Healthy controls

Healthy people without any pulmonary conditions

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients with confirmed sarcoidosis

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gelderse Vallei Hospital

OTHER

Sponsor Role: collaborator

Atrium Medical Center

OTHER

Sponsor Role: collaborator

Maastricht University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rianne Fijten, MSc

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

References

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.

Reference Type: DERIVED

PMID: 28775245 (View on PubMed)

Other Identifiers

BC/1408-389

Identifier Type: -

Identifier Source: org_study_id