Connective Tissue Diseases and Lung Manifestations | NCT04095351

Studies
Connective Tissue Diseases and Lung Manifestations

NCT04095351

Sponsor

Medical University Innsbruck

Status

Recruiting

Last Update Posted

May 27, 2020Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Connective Tissue Diseases
Interstitial Lung Disease
Systemic Sclerosis

Interventions

Pulmonary function test
Imaging
Blood sampling

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2019Actual

Primary Completion Date

Mar 1, 2021Estimated

Completion Date

Oct 1, 2034Estimated

First Submitted Date

Sep 13, 2019

First Submission Date that Met QC Criteria

Sep 18, 2019

First Posted Date

Sep 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2020

Last Update Posted Date

May 27, 2020Actual

Name	Class
Boehringer Ingelheim	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
Pulmonary function test	Diagnostic Test	Spirometry or plethysmography, measurement of diffusion capacity
Imaging	Diagnostic Test	Thoracic ultrasound, HRCT as scheduled within routine clinical examinations, echocardiography
Blood sampling	Biological	Standard laboratory test for CTDs as part of routine clinical examination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decline in forced vital capacity	Absolute decline from baseline in forced vital capacity percent predicted. Lung function tests are performed by a trained professional.	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	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.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Real-life cohort of CTD patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Magdalena Aichner, MD	Contact	+43 512-504-83765		magdalena.aichner@i-med.ac.at
Graziella Plank	Contact	+43 512-504-81884		graziella.plank@i-med.ac.at

Overall Officials

Name	Affiliation	Role
Judith Löffler-Ragg, Prof. MD	Medical University Innsbruck, Department Internal Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University Innsbruck, Department of Internal Medicine II	Recruiting	Innsbruck		6020	Austria

Condition Browse Module

MeSH Terms

ID	Term
D003240	Connective Tissue Diseases
D017563	Lung Diseases, Interstitial
D012595	Scleroderma, Systemic

Ancestor Terms

ID	Term
D017437	Skin and Connective Tissue Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012129	Respiratory Function Tests
D003952	Diagnostic Imaging
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D003948	Diagnostic Techniques, Respiratory System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D013048	Specimen Handling

Browse Leaves

Not provided

Browse Branches

Not provided

Description

From each patient with proven systemic sclerosis one serum vial of 10 ml and 2 EDTA vials à 10 ml will be taken. Peripheral blood mononuclear cells are isolated from the EDTA blood samples, an stored at -80°C.The serum samples will be centrifuged and the resulting serum is collected in cryovials and stored at -80 °C until measurement. Samples and data will be stored and archived central according to the new standards of the biobank facility of the medical university of Innsbruck.