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

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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
Gelderse Vallei Hospital
Atrium Medical Center
Information provided by (Responsible Party):
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.

Condition or disease

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis
U.S. FDA Resources

Sarcoidosis patients
Clinically relevant sarcoidosis patients with different stages and treatments.
Healthy controls
Healthy people without any pulmonary conditions

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Inclusion Criteria:

  • Patients with confirmed sarcoidosis

Exclusion Criteria:

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

Information from the National Library of Medicine

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

Sponsors and Collaborators
Maastricht University
Gelderse Vallei Hospital
Atrium Medical Center
Principal Investigator: Rianne Fijten, MSc Maastricht University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University
ClinicalTrials.gov Identifier: NCT02361281     History of Changes
Other Study ID Numbers: BC/1408-389
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: February 11, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Lymphatic Diseases