Assessing the role of local inflammatory, fibroproliferative, and osteogenic biomarkers in Systemic Sclerosis related Interstitial Lung Disease.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25588

Enrollment

Registered

2020-09-22

Start date

2020-09-09

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Systemic Sclerosis

Interventions

None

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Level of IL-6 in BAL fluid	—

Secondary

Measure	Time frame
2. Inflammatory, fibroproliferative and osteogenic cytokines in BAL fluids 3. Degree of proinflammatory, profibrotic and osteogenic differentiation of fibroblasts isolated from lung BAL and bronchial biopsies 4. Degree of tissue markers involved in the calcification process and SSc progression in bronchial biopsies 5. Degree of other serum markers of the calcification process: T50, calcium, phosphorus, parathormone, fetuin-A, Fibroblast Growth Factor-23 (FGF23), aKlotho; 6. Degree and extent of pulmonary involvement of ILD and pulmonary ossifications by lung function (FVC, FEV1, DLCO), and HRCT 7. Degree of vasculopathy by: noninvasive nailfold capillary microscopy; arterial stiffness; digital artery involvement as assessed with ultrasound; 8. Clinical parameters on SSc organ and degree of skin and additional organ involvement, SSc-antibody profile, medication use, and comorbidities.	—

Measure

Time frame

2. Inflammatory, fibroproliferative and osteogenic cytokines in BAL fluids 3. Degree of proinflammatory, profibrotic and osteogenic differentiation of fibroblasts isolated from lung BAL and bronchial biopsies 4. Degree of tissue markers involved in the calcification process and SSc progression in bronchial biopsies 5. Degree of other serum markers of the calcification process: T50, calcium, phosphorus, parathormone, fetuin-A, Fibroblast Growth Factor-23 (FGF23), aKlotho; 6. Degree and extent of pulmonary involvement of ILD and pulmonary ossifications by lung function (FVC, FEV1, DLCO), and HRCT 7. Degree of vasculopathy by: noninvasive nailfold capillary microscopy; arterial stiffness; digital artery involvement as assessed with ultrasound; 8. Clinical parameters on SSc organ and degree of skin and additional organ involvement, SSc-antibody profile, medication use, and comorbidities.

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Contacts

Public ContactDouwe Mulder

University Medical Center Groningen

d.j.mulder@umcg.nl003103616161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)