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Connective Tissue Diseases and Lung Manifestations (Colipris)

M

Medical University Innsbruck

Status

Enrolling

Conditions

Systemic Sclerosis
Connective Tissue Diseases
Interstitial Lung Disease

Treatments

Biological: Blood sampling
Diagnostic Test: Imaging
Diagnostic Test: Pulmonary function test

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04095351
20190506-2003

Details and patient eligibility

About

Despite a number of prospective studies already initiated in the past years, the current epidemiology and course of interstitial lung disease (ILD) and pulmonary hypertension (PH) in patients with connective tissue disease (CTD) is still not well defined, particularly regarding its prevalence, incidence and the management of a broad spectrum of disease presentations.

Major challenges include the identification of patients with progressive disease, the appropriate time point of therapeutic intervention and the underlying driver of disease (inflammatory or pro-fibrotic stimulus or both?).

To address these issues in Western Austria, a progressive registry of patients with CTD exploring routine clinical and pathophysiological characteristics of ILD and PH will be conducted. This multidisciplinary, prospective and observational registry aims to collect comprehensive clinical data on incidence, prevalence and course of disease regarding all PH and ILD presentations in a real-world setting.

Full description

Specifically, this registry will collect demographic data, disease-related clinical data, routine laboratory values (including antibody-profile and iron status), diagnostic procedures, significant comorbidities, therapeutic managements (e.g. thoracic ultrasound, HRCT), and disease outcomes over 10 years.

In addition, blood biobank samples for translational research will be collected in a subgroup of patients with systemic sclerosis over serial time points to study the systemic inflammatory and profibrotic phenotype of patients. In summary, this registry will monitor the disease course of pulmonary manifestations of patients with CTD and may be hypothesis-generating and provide new insights in underlying inflammatory/pro-fibrotic patterns.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The inclusion criteria are adult patients (≥18 years) diagnosed with CTD with signed informed consent.

Exclusion criteria

  • Exclusion criteria are patients with a serious co-morbidity interfering with the course of interstitial lung disease or pulmonary hypertension.

Trial contacts and locations

1

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Central trial contact

Magdalena Aichner, MD; Graziella Plank

Data sourced from clinicaltrials.gov

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