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The role of regulatory T cells in the pathogenesis of sarcoidosis.

Completed
Conditions
sarcoidosis
10024967
Registration Number
NL-OMON45069
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
140
Inclusion Criteria

Sarcoidosis patients should have:
- Newly diagnosed pulmonary sarcoidosis, established using the criteria of the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG)
- Written informed consent
- Age > 18;Healthy controls should have:
- Written informed consent;
- Age > 18.;Tuberculosis patients should have:
- Newly diagnosed tuberculosis with pulmonary caseating granulomas.
o Diagnosis is based on European Respiratory Society (ERS) guidelines.
- Written informed consent;
- Age > 18.

Exclusion Criteria

Sarcoidosis patients may not have:
- Used oral corticosteroids, antimycotica or antibiotics 1 weeks prior to the collection of materials.
- Used immunosuppressive medication or biologicals 3 months prior to the collection of materials.
- A possible infection of the upper- or lower respiratory tract 4 weeks prior to the collection of materials.
- Other diseases which could influence pulmonary function, granuloma formation and/or the immune system, such as:
o Chronic obstructive pulmonary disorder (COPD) or astma in the medical history;
o Auto-immune diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), myasthenia gravis or Goodpasture*s syndrome;
o Malignancies;
o Human immunodeficiency virus (HIV);
o Pregnancy;
o Allergies such as allergic rhinitis. ;Healthy controls may not have:
- Sarcoidosis;
- An abnormal spirometry with a FVC or FEV1 below the 80% of the predicted value;
- A liaison with the coordinating or principal investigator, which could likely influence the decision to participate in this study voluntarily (in concordance with the WMO -article 5);
- See exclusion criteria sarcoidosis patients. ;Tuberculosis patients may not have:
- Sarcoidosis
- See exclusion criteria sarcoidosis patients.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Number, distribution and phenotype of Tregs in peripheral blood, lung (BAL and<br /><br>EBBs) and lymph nodes (FNAs); the suppressive function of Tregs on allogenic T<br /><br>cell proliferation in the peripheral blood; viability and apoptotic<br /><br>susceptibility of Tregs in the peripheral blood; the cytokine and chemokine<br /><br>environment of the Tregs in peripheral blood, lung and lymph nodes; the gene<br /><br>expression profile of Tregs in the peripheral blood, lung and lymph nodes<br /><br>(including apoptosis-related and survival genes). </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Clinical parameters indicating disease progression or resolution after two<br /><br>years.</p><br>
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