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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45069

Enrollment

140

Registered

2012-10-18

Start date

2012-12-12

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sarcoidosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Number, distribution and phenotype of Tregs in peripheral blood, lung (BAL and EBBs) and lymph nodes (FNAs); the suppressive function of Tregs on allogenic T cell proliferation in the peripheral blood; viability and apoptotic susceptibility of Tregs in the peripheral blood; the cytokine and chemokine environment of the Tregs in peripheral blood, lung and lymph nodes; the gene expression profile of Tregs in the peripheral blood, lung and lymph nodes (including apoptosis-related and survival genes).	—

Measure

Time frame

Number, distribution and phenotype of Tregs in peripheral blood, lung (BAL and EBBs) and lymph nodes (FNAs); the suppressive function of Tregs on allogenic T cell proliferation in the peripheral blood; viability and apoptotic susceptibility of Tregs in the peripheral blood; the cytokine and chemokine environment of the Tregs in peripheral blood, lung and lymph nodes; the gene expression profile of Tregs in the peripheral blood, lung and lymph nodes (including apoptosis-related and survival genes).

—

Secondary

Measure	Time frame
Clinical parameters indicating disease progression or resolution after two years.	—

Countries

Netherlands

Outcome results