Connective Tissue DiseasesColiprisNCT04095351
Connective Tissue Diseases and Lung Manifestations
An observational study of Connective Tissue Diseases and Interstitial Lung Disease, run by Medical University Innsbruck at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Connective Tissue Diseases, Interstitial Lung Disease, Systemic Sclerosis
- What is being tested?
- Pulmonary function test, Imaging and Blood sampling
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- 9 Dec 2019to 1 Oct 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Real-life cohort of CTD patients
Who may be able to join
- The inclusion criteria are adult patients (≥18 years) diagnosed with CTD with signed informed consent.
Who cannot join
- Exclusion criteria are patients with a serious co-morbidity interfering with the course of interstitial lung disease or pulmonary hypertension.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University Innsbruck, Department of Internal Medicine II
Innsbruck, 6020
Graziella Plank
About this study
Official title: Connective Tissue Diseases and Lung Manifestations Prospective Trial With Focus on Systemic Sclerosis (Colipris)
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.
Read the detailed 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.
- Being tested
- Pulmonary function test, Imaging, Blood sampling
- Medical subject headings
- Connective Tissue Diseases, Lung Diseases, Interstitial, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary function testDiagnostic test
Spirometry or plethysmography, measurement of diffusion capacity
ImagingDiagnostic test
Thoracic ultrasound, HRCT as scheduled within routine clinical examinations, echocardiography
Blood samplingBiological
Standard laboratory test for CTDs as part of routine clinical examination
What is being measured
The primary outcome is the main question the study is designed to answer.
Decline in forced vital capacity
Absolute decline from baseline in forced vital capacity percent predicted. Lung function tests are performed by a trained professional.
Measured: 1 year
Increase in the modified Rodnan Skin Score
Change in the modified Rodnan Skin Score from baseline of >5 Points assessed by a trained professional
Measured: 1 year
Decline in Diffusion capacity for carbon monoxide
Absolute decline from baseline in diffusion capacity for carbon monoxide in percent measured. Lung function tests are performed by a trained professional.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start9 Dec 2019
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Connective Tissue DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Judith Löffler-Ragg, Prof. MD, Principal investigator, Medical University Innsbruck, Department Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095351
- Sponsor's protocol ID
- 20190506-2003
- Acronym
- Colipris
- Status last verified
- Sep 2019
- First submitted
- 13 Sep 2019
- Last updated
- 27 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connective Tissue Diseases and Lung Manifestations Prospective Trial With Focus on Systemic Sclerosis (Colipris)
- ClinicalTrials.gov ID
- NCT04095351
- Acronym / sponsor ID
- Colipris / 20190506-2003
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Oct 2034 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Real-life cohort of CTD patients
Key inclusion criteria (1 listed)
- The inclusion criteria are adult patients (≥18 years) diagnosed with CTD with signed informed consent.
Key exclusion criteria (1 listed)
- Exclusion criteria are patients with a serious co-morbidity interfering with the course of interstitial lung disease or pulmonary hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary function testSpirometry or plethysmography, measurement of diffusion capacity | Diagnostic test | – |
| ImagingThoracic ultrasound, HRCT as scheduled within routine clinical examinations, echocardiography | Diagnostic test | – |
| Blood samplingStandard laboratory test for CTDs as part of routine clinical examination | Biological | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Judith Löffler-Ragg, Prof. MD principal investigator
Medical University Innsbruck, Department Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Connective Tissue Diseases and Interstitial Lung Disease, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magdalena Aichner, MD (+43 512-504-83765, magdalena.aichner@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decline in forced vital capacity (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.