Assessing the role of local inflammatory, fibroproliferative, and osteogenic biomarkers in Systemic Sclerosis related Interstitial Lung Disease.
Recruiting
- Conditions
- Systemic Sclerosis
- Registration Number
- NL-OMON25588
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
• Age 18-70 years
• Written informed consent
• Formal diagnosis of Systemic Sclerosis on ACR/EULAR criteria
• Formal diagnosis of interstitial lung disease (for 15 of 20 included patients)
Exclusion Criteria
• Patients who are mentally incompetent
• Vascular event or chemotherapy in the preceding 3 months
• Inflammation of unknown origin
• Other lung disease present
• Use of anti-inflammatory medication or antibiotics
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Level of IL-6 in BAL fluid<br>
- Secondary Outcome Measures
Name Time Method 2. Inflammatory, fibroproliferative and osteogenic cytokines in BAL fluids<br>3. Degree of proinflammatory, profibrotic and osteogenic differentiation of fibroblasts isolated from lung BAL and bronchial biopsies<br>4. Degree of tissue markers involved in the calcification process and SSc progression in bronchial biopsies<br>5. Degree of other serum markers of the calcification process: T50, calcium, phosphorus, parathormone, fetuin-A, Fibroblast Growth Factor-23 (FGF23), aKlotho;<br>6. Degree and extent of pulmonary involvement of ILD and pulmonary ossifications by lung function (FVC, FEV1, DLCO), and HRCT<br>7. Degree of vasculopathy by: noninvasive nailfold capillary microscopy; arterial stiffness; digital artery involvement as assessed with ultrasound;<br>8. Clinical parameters on SSc organ and degree of skin and additional organ involvement, SSc-antibody profile, medication use, and comorbidities.