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

NCT02361281 | Unknown

• 1 other identifier: BC/1408-389
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sarcoidosis patients

Clinically relevant sarcoidosis patients with different stages and treatments.

Healthy controls

Healthy people without any pulmonary conditions

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patients with confirmed sarcoidosis

You may not qualify if:

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

Sponsors & Collaborators

• Maastricht University: lead
• Gelderse Vallei Hospital: collaborator
• Atrium Medical Center: collaborator

Related Publications (1)

• 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.

  PMID: 28775245 DERIVED

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Rianne Fijten, MSc

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 11, 2015
• Study Start: December 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 11, 2015

Record last verified: 2015-02