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Connective Tissue Diseases and Lung Manifestations (Colipris)

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ClinicalTrials.gov Identifier: NCT04095351
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Medical University Innsbruck

Brief Summary:

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.

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.


Condition or disease Intervention/treatment
Connective Tissue Diseases Interstitial Lung Disease Systemic Sclerosis Diagnostic Test: Pulmonary function test Diagnostic Test: Imaging Biological: Blood sampling

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Connective Tissue Diseases and Lung Manifestations Prospective Trial With Focus on Systemic Sclerosis (Colipris)
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2034



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Real-life cohort of CTD patients
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Magdalena Aichner, Dr. +43 512-504-83765 magdalena.aichner@i-med.ac.at
Contact: Graziella Plank +43 512-504-81884 graziella.plank@i-med.ac.at

Sponsors and Collaborators
Medical University Innsbruck
Boehringer Ingelheim
Investigators
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Principal Investigator: Judith Löffler-Ragg, Ao. Univ.-Prof. Dr. Medical University Innsbruck, Department Internal Medicine

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Responsible Party: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT04095351     History of Changes
Other Study ID Numbers: 20190506-2003
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Sclerosis
Pathologic Processes
Respiratory Tract Diseases
Skin Diseases