Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT05635032
Status:
RECRUITING
Last Update Posted:
2023-10-27
First Post:
2022-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fibrosing ILD Biomarkers That Rule Acceleration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D012507', 'term': 'Sarcoidosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Creation of a biobank of peripheral blood (plasma, serum, DNA, RNA), bronchoalveolar lavage, pharyngeal swabs and lung tissue.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-24', 'studyFirstSubmitDate': '2022-11-22', 'studyFirstSubmitQcDate': '2022-11-22', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Variation in Computed Tomography Lung Densitometry', 'timeFrame': '36 months'}, {'measure': 'Proportion of patients varying FVC ⩾5% predicted within 1 year of follow-up', 'timeFrame': '36 months'}, {'measure': 'Proportion of patients varying DLCO ⩾10% predicted within 1 year of follow-up', 'timeFrame': '36 months'}, {'measure': 'Time to progression or exacerbation', 'timeFrame': '36 months'}, {'measure': 'Survival', 'timeFrame': '36 months'}], 'primaryOutcomes': [{'measure': 'Discover biomarkers in progressive pulmonary fibrosis', 'timeFrame': '36 months', 'description': 'Characterization of blood and tissue transcriptional signatures of progression and acute exacerbations, and validate findings at the protein expression level, which could be easily converted for clinical use as biomarkers.'}], 'secondaryOutcomes': [{'measure': 'Change in microbiome profile in progressive pulmonary fibrosis', 'timeFrame': '24 months', 'description': 'To assess the impact of microbiome features in clinical progression and higher risk of acute exacerbation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Fibrosis', 'Sarcoidosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://fibralung.pt/', 'label': 'Project presentation website'}]}, 'descriptionModule': {'briefSummary': 'FIBRALUNG is a prospective cohort study with biobank of samples from patients with pulmonary fibrosis, aiming to explore the molecular determinants of different clinical outcomes, acute exacerbations and mortality. We expect to gain deeper insight into fibroproliferative common pathways, particularly between idiopathic pulmonary fibrosis and fibrotic hypersensitivity pneumonitis, paving the way for new biomarkers that reflect the progressive phenotype, that eventually will support new targeted therapies.\n\nOther idiopathic interstitial pneumonias, connective tissue disease-related interstitial lung diseases and sarcoidosis patients will be also recruited and their biological samples stored for further analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited from the Interstitial Lung Diseases unit of Centro Hospitalar Universitário de São João (Porto, Portugal).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18-80 years\n* People undergoing blood collection, lung biopsy and/or BAL as part of their diagnostic workup\n* Willingness to undergo the follow-up protocol evaluations\n* Treatment-naïve for disease-modifying drugs\n* An HRCT scan performed within the last 12 months showing ≥10% fibrosis extent of the lungs\n\nExclusion Criteria:\n\n* People who cannot give informed consent\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05635032', 'acronym': 'FIBRALUNG', 'briefTitle': 'Fibrosing ILD Biomarkers That Rule Acceleration', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'Host-microbiome Interactions in the Quest for Fibrosing ILD Biomarkers That Rule Acceleration', 'orgStudyIdInfo': {'id': 'FIBRALUNG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IPF', 'description': 'Patients with Idiophatic Pulmonary Fibrosis (IPF), serving as a prototype of a progressive fibroproliferative disorder.', 'interventionNames': ['Other: Comprehensive clinical assessment and biological samples collection']}, {'label': 'Progressive Pulmonary Fibrosis (non-IPF)', 'description': 'Patients with non-IPF interstitial lung diseases, presenting a progressive fibrosing phenotype, or acute exacerbations.', 'interventionNames': ['Other: Comprehensive clinical assessment and biological samples collection']}, {'label': 'Non-Progressive Pulmonary Fibrosis (non-IPF)', 'description': 'Patients with fibrotic non-IPF interstitial lung diseases that are stable during a minimum follow-up of 24 months.', 'interventionNames': ['Other: Comprehensive clinical assessment and biological samples collection']}], 'interventions': [{'name': 'Comprehensive clinical assessment and biological samples collection', 'type': 'OTHER', 'description': 'To establish the first Portuguese registry and biobank of PF-ILDs, comprising both extensive patient-level data, and systematic biological sampling (DNA, RNA, plasma, serum, bronchoalveolar lavage, lung tissue) at baseline and repeated biological sampling of blood and pharyngeal swabs performed at 6, 12 and 18 months, or whenever progression criteria are met or an acute exacerbation occurs. Participants will have regular visits at maximum intervals of 6 months, when their clinical condition and lung function tests are reassessed. A high resolution computed tomography (HRCT) scan of the lung will be performed every 12 months. Progressive fibrosis will be diagnosed based on meeting at least two of the following three criteria, occurring within the last year: (i) worsening of symptoms; (ii) absolute decline in FVC ≥5% predicted or absolute decline in DLCO (corrected for Hb) ≥10% predicted; (iii) increased extent of fibrotic changes on HRCT.', 'armGroupLabels': ['IPF', 'Non-Progressive Pulmonary Fibrosis (non-IPF)', 'Progressive Pulmonary Fibrosis (non-IPF)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Helder Novais Bastos', 'role': 'CONTACT', 'email': 'hnovaisbastos@med.up.pt'}, {'name': 'Rita Santos', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centro Hospitalar Universitário São João', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'centralContacts': [{'name': 'Helder Novais Bastos, MD, PhD', 'role': 'CONTACT', 'email': 'hnovaisbastos@med.up.pt', 'phone': '(+351) 220408800'}, {'name': 'Janete Santos, PhD', 'role': 'CONTACT', 'email': 'investigaclinica@med.up.pt', 'phone': '(+351) 225 513 600'}], 'overallOfficials': [{'name': 'Helder Novais Bastos, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade do Porto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Porto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centro Hospitalar De São João, E.P.E.', 'class': 'OTHER'}, {'name': 'Instituto de Investigação e Inovação em Saúde (i3S)', 'class': 'UNKNOWN'}, {'name': 'Fundação para a Ciência e a Tecnologia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}