Brief Summary

Sarcoidosis is a chronic condition which predominantly affects the lungs and lymph glands within the chest, however, may affect any organ within the body. At the present time, very little is known as to the exact cause of sarcoidosis and it is widely believed that the condition arises due to overreaction of the immune system to an unknown trigger in the environment such as an infection. Alongside this, the clinical course and progression of the condition varies considerably; some patients have a very mild form which does require any specific treatment, where as other patients develop a more severe form which can lead to permanent scarring (fibrosis) of the lungs if left untreated. At the present time it is difficult to predict how a patient will be affected by their sarcoidosis as there is a distinct lack of clinically useful markers which help predict prognosis and identify people at risk of disease progression or those who require treatment. The main aims of this study are to use a technique which captures and analyses breath samples to provide a profile of the chemicals known as volatile organic compounds (VOCs) which are present in the exhaled breath of patients with sarcoidosis. Specifically the study would look to see if these VOCs are different in patients with sarcoidosis compared to people who do not have sarcoidosis or any lung conditions. In addition, the study would look to see how these breath profiles relate to potential infections, change over time or in response to treatment with steroids. The study will involve a total of 80 patients presenting with suspected sarcoidosis and involve a total of four study visits over the course of twelve months. During each study visit a sample of breath will be collected alongside a blood test to look for markers of disease activity as well as completion of two questionnaires relating to a patients degree of breathlessness and quality of life. At the start of the study an additional questionnaire will be completed to identify possible risk factors for the development of sarcoidosis as well as the option of providing a sample of blood for genetic testing (which is voluntary). In patients undergoing a bronchoscopy or endobronchial ultrasound (EBUS), a sample of fluid which naturally lines the airways (bronchoalveolar lavage) will also be taken and used for metagenomic sequencing to try and identify any microbes which might be present within the lung and airways.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach

1 country

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3 years study duration

Study Start

First participant enrolled

October 1, 2018

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed

12 months until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2021

Completed

Last Updated

November 2, 2021

Status Verified

November 1, 2021

Enrollment Period

2.5 years

First QC Date

April 8, 2019

Last Update Submit

November 1, 2021

Conditions

Pulmonary Sarcoidosis

Keywords

SarcoidosisVolatile Organic CompoundsBreathomics

Outcome Measures

Primary Outcomes (1)

Baseline volatile organic compounds (VOCs) in breath samples in patients with sarcoidosis compared to healthy controls and in relation to the lung microbiome.
The investigators would like to determine if the VOC profile obtained in breath samples from patients with sarcoidosis is different from people who do not have the condition and furthermore to determine if this is related to any microbes which might be present within the lung microbiome.
The start of the study.

Secondary Outcomes (4)

Baseline VOCs in relation to markers of disease progression over twelve months.
Twelve months.
Exhaled VOC profiles related to markers of steroid response.
Twelve months.
Exhaled VOC profiles and reproducibility in sarcoidosis
Two weeks after starting the study.
Exhaled VOC profiles related to potential microbial markers of disease including any bacterial or fungal agents present in tissue obtained during EBUS/transbronchial lung biopsy.
The start of the study.

Study Arms (2)

Patients with suspected sarcoidosis

Patients presenting with suspected sarcoidosis.

Other: Breath AnalysisOther: Pulmonary Function TestsOther: Blood sampling and storage for genetic analysisOther: Blood sampling and storage of plasma for metabolomic analysisOther: Bronchoalveolar lavageOther: Sputum Culture

Healthy controls

Healthy controls matched for age and gender. Recruitment of spouses and partners will also take place where possible.

Other: Breath AnalysisOther: Spirometry

Interventions

Breath AnalysisOTHER

Breath analysis using the ReCIVA device will take place during each study visit.

Healthy controlsPatients with suspected sarcoidosis

Pulmonary Function TestsOTHER

Full Pulmonary Function Tests will be performed at baseline and during each study visit if not performed as part of routine clinical care.