Connective Tissue Diseases and Lung Manifestations (Colipris)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04095351|
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : May 27, 2020
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.
|Condition or disease||Intervention/treatment|
|Connective Tissue Diseases Interstitial Lung Disease Systemic Sclerosis||Diagnostic Test: Pulmonary function test Diagnostic Test: Imaging Biological: Blood sampling|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||120 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Connective Tissue Diseases and Lung Manifestations Prospective Trial With Focus on Systemic Sclerosis (Colipris)|
|Actual Study Start Date :||December 9, 2019|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||October 1, 2034|
- Diagnostic Test: Pulmonary function test
Spirometry or plethysmography, measurement of diffusion capacity
- Diagnostic Test: Imaging
Thoracic ultrasound, HRCT as scheduled within routine clinical examinations, echocardiography
- Biological: Blood sampling
Standard laboratory test for CTDs as part of routine clinical examination
- Decline in forced vital capacity [ Time Frame: 1 year ]Absolute decline from baseline in forced vital capacity percent predicted. Lung function tests are performed by a trained professional.
- Increase in the modified Rodnan Skin Score [ Time Frame: 1 year ]Change in the modified Rodnan Skin Score from baseline of >5 Points assessed by a trained professional
- Decline in Diffusion capacity for carbon monoxide [ Time Frame: 1 year ]Absolute decline from baseline in diffusion capacity for carbon monoxide in percent measured. Lung function tests are performed by a trained professional.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095351
|Contact: Magdalena Aichner, MD||+43 email@example.com|
|Contact: Graziella Plank||+43 firstname.lastname@example.org|
|Medical University Innsbruck, Department of Internal Medicine II||Recruiting|
|Innsbruck, Austria, 6020|
|Contact: Graziella Plank|
|Principal Investigator:||Judith Löffler-Ragg, Prof. MD||Medical University Innsbruck, Department Internal Medicine|