Clinical trial: Breath Analysis in Patients With Suspected Sarcoidosis: The VOCs-IS Study (NCT04318392)

Eligibility 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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs.  She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications.  On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli.

Patient description (patient's own words): I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB.

Does the patient match the trial criteria? 1