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Breath Analysis in Patients With Suspected Sarcoidosis: The VOCs-IS Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318392
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

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.


Condition or disease Intervention/treatment
Pulmonary Sarcoidosis Other: Breath Analysis Other: Pulmonary Function Tests Other: Blood sampling and storage for genetic analysis Other: Blood sampling and storage of plasma for metabolomic analysis Other: Bronchoalveolar lavage Other: Sputum Culture Other: Spirometry

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Non-invasive Profiling of Breath Volatile Organic Compounds in Sarcoidosis: Relation to the Lung Microbiome and Markers of Disease Progression.
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 3, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Group/Cohort Intervention/treatment
Patients with suspected sarcoidosis
Patients presenting with suspected sarcoidosis.
Other: Breath Analysis
Breath analysis using the ReCIVA device will take place during each study visit.

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

Other: Blood sampling and storage for genetic analysis
Additional voluntary consent will be sought for blood sampling and storage for genetic analysis at baseline.

Other: Blood sampling and storage of plasma for metabolomic analysis
Blood sampling and storage of plasma for metabolomic analysis will take place during each study visit.

Other: Bronchoalveolar lavage
Bronchoalveolar lavage will be performed at baseline on all participants undergoing investigation with bronchoscopy or EBUS as part of routine clinical care for investigation of suspected sarcoidosis.
Other Name: BAL

Other: Sputum Culture
Sputum will be collected during each study visit if the patient can spontaneously expectorate and will be sent for routine microbial analysis as well as metagenomic sequencing.

Healthy controls
Healthy controls matched for age and gender. Recruitment of spouses and partners will also take place where possible.
Other: Breath Analysis
Breath analysis using the ReCIVA device will take place during each study visit.

Other: Spirometry
Spirometry will be performed on all healthy controls prior to enrolment into the study




Primary Outcome Measures :
  1. Baseline volatile organic compounds (VOCs) in breath samples in patients with sarcoidosis compared to healthy controls and in relation to the lung microbiome. [ Time Frame: The start of the study. ]
    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.


Secondary Outcome Measures :
  1. Baseline VOCs in relation to markers of disease progression over twelve months. [ Time Frame: Twelve months. ]
    The investigators would like to determine if the VOC breath profile is different in patients who have evidence of disease progression which is indicated by changes in the forced vital capacity, changes on high resolution computerised tomography scan, medical research council dyspnoea score and King's sarcoidosis quality of life questionnaire scores over a period of twelve months.

  2. Exhaled VOC profiles related to markers of steroid response. [ Time Frame: Twelve months. ]
    The investigators would like to determine if the VOC breath profile differs in patients who receive treatment and those that do not over a period of twelve months.

  3. Exhaled VOC profiles and reproducibility in sarcoidosis [ Time Frame: Two weeks after starting the study. ]
    The investigators would like to determine if the breath profiles obtained in patient with sarcoidosis are able to be reproduced in those who undergo repeated breath sampling at two weeks after starting the study.

  4. 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. [ Time Frame: The start of the study. ]
    The investigators would like to determine if the VOC breath profile related to microbes which might be present within lymph node and lung tissue obtained in patients with suspected sarcoidosis.


Biospecimen Retention:   Samples With DNA
Plasma stored for metabolomic analysis. Blood stored for future genetic analysis (voluntary).


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients presenting with suspected sarcoidosis
Criteria

Participants with Suspected Sarcoidosis:

Inclusion Criteria:

  • Age >18 years
  • Suspected pulmonary sarcoidosis undergoing investigations for diagnosis, staging and treatment consideration or discussion at a designated interstitial lung disease multidisciplinary meeting (this includes participants with stage I disease characterised by the presence of hilar or mediastinal lymphadenopathy)

Exclusion Criteria:

  • Significant respiratory co-morbidity where the primary major respiratory diagnosis is not sarcoidosis
  • Current smoker or ex-smoker (having ceased smoking <3 months duration)
  • Extra-pulmonary sarcoidosis without any evidence of pulmonary involvement (characterised by normal pulmonary function tests and no radiological evidence of thoracic sarcoidosis on HRCT or chest radiography)
  • Inability to provide written consent
  • Self-reported lower respiratory tract infection, or treatment with antibiotics for a lower respiratory tract infection or any other infection within the previous 4 weeks

Healthy Volunteers:

Inclusion Criteria:

  • Age >18 - 70 years
  • Normal spirometry

Exclusion Criteria:

  • Current smoker or ex-smoker (having ceased smoking <3 months duration)
  • History of uncontrolled diabetes, respiratory, inflammatory gastroenterological, autoimmune or renal disease (characterised by an eGFR <30ml/min/1.73m2)
  • Self-reported lower respiratory tract infection, or treatment with antibiotics for a lower respiratory tract infection or any other infection within the previous 4 weeks
  • Inability to provide written consent

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): NCT04318392


Contacts
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Contact: Karen Rhodes (Sponsor) 0161 291 5768 Karen.rhodes@mft.nhs.uk

Locations
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United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust Recruiting
Norwich, Norfolk, United Kingdom, NR4 7UY
Contact: Dayle Terrington, MBBS    01603 286286    Dayle.terrington@nnuh.nhs.uk   
Sub-Investigator: Andrew Wilson, MB ChB         
Wythenshawe Hospital, Manchester University NHS Foundation Trust Recruiting
Manchester, United Kingdom, M23 9LT
Contact: Conal Hayton, MB ChB    0161 998 7070    Conal.hayton@mft.nhs.uk   
Principal Investigator: Stephen Fowler, MD FRCP         
Sponsors and Collaborators
Manchester University NHS Foundation Trust
Norfolk and Norwich University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Stephen Fowler, MD FRCP The University of Manchester
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Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04318392    
Other Study ID Numbers: B00081
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manchester University NHS Foundation Trust:
Sarcoidosis
Volatile Organic Compounds
Breathomics
Additional relevant MeSH terms:
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Sarcoidosis, Pulmonary
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases