Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT04095351
Status:
RECRUITING
Last Update Posted:
2020-05-27
First Post:
2019-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Connective Tissue Diseases and Lung Manifestations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2034-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-25', 'studyFirstSubmitDate': '2019-09-13', 'studyFirstSubmitQcDate': '2019-09-18', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decline in forced vital capacity', 'timeFrame': '1 year', 'description': 'Absolute decline from baseline in forced vital capacity percent predicted. Lung function tests are performed by a trained professional.'}, {'measure': 'Increase in the modified Rodnan Skin Score', 'timeFrame': '1 year', 'description': 'Change in the modified Rodnan Skin Score from baseline of \\>5 Points assessed by a trained professional'}, {'measure': 'Decline in Diffusion capacity for carbon monoxide', 'timeFrame': '1 year', 'description': 'Absolute decline from baseline in diffusion capacity for carbon monoxide in percent measured. Lung function tests are performed by a trained professional.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Connective Tissue Diseases', 'Interstitial Lung Disease', 'Systemic Sclerosis']}, 'descriptionModule': {'briefSummary': '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.\n\nMajor 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?).\n\nTo 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.', 'detailedDescription': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Real-life cohort of CTD patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria are adult patients (≥18 years) diagnosed with CTD with signed informed consent.\n\nExclusion Criteria:\n\n* Exclusion criteria are patients with a serious co-morbidity interfering with the course of interstitial lung disease or pulmonary hypertension.'}, 'identificationModule': {'nctId': 'NCT04095351', 'acronym': 'Colipris', 'briefTitle': 'Connective Tissue Diseases and Lung Manifestations', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Connective Tissue Diseases and Lung Manifestations Prospective Trial With Focus on Systemic Sclerosis (Colipris)', 'orgStudyIdInfo': {'id': '20190506-2003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pulmonary function test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Spirometry or plethysmography, measurement of diffusion capacity'}, {'name': 'Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Thoracic ultrasound, HRCT as scheduled within routine clinical examinations, echocardiography'}, {'name': 'Blood sampling', 'type': 'BIOLOGICAL', 'description': 'Standard laboratory test for CTDs as part of routine clinical examination'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Graziella Plank', 'role': 'CONTACT'}], 'facility': 'Medical University Innsbruck, Department of Internal Medicine II', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'centralContacts': [{'name': 'Magdalena Aichner, MD', 'role': 'CONTACT', 'email': 'magdalena.aichner@i-med.ac.at', 'phone': '+43 512-504-83765'}, {'name': 'Graziella Plank', 'role': 'CONTACT', 'email': 'graziella.plank@i-med.ac.at', 'phone': '+43 512-504-81884'}], 'overallOfficials': [{'name': 'Judith Löffler-Ragg, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Innsbruck, Department Internal Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}