[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624037":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":35,"studyPopulation":36,"armGroups":31,"interventions":31,"overallOfficials":31,"centralContacts":37,"locations":31,"responsibleParty":47,"collaborators":31,"id":51,"slug":31,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":31,"studyType":64,"phases":31,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":81,"whyStopped":31,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":31},{"fullName":5,"class":6},"University of Modena and Reggio Emilia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Disease progression (guideline-based functional\u002Fcomposite criteria)","Disease progression defined using guideline-based criteria derived from routinely collected clinical data (e.g., decline in lung function and\u002For composite progression definitions as per the shared operational document).","From baseline (index date) up to 12 months and up to end of available follow-up (maximum: 31 December 2025)",[14,18,22,25,28],{"measure":15,"description":16,"timeFrame":17},"Acute exacerbation of IPF (AE-IPF)","Occurrence of AE-IPF during follow-up, adjudicated from routine clinical documentation using standardised operational definitions shared across centres.","From baseline to end of follow-up (maximum: 31 December 2025)",{"measure":19,"description":20,"timeFrame":21},"Real-world response to antifibrotic therapy","Treatment response assessed in routine clinical practice using longitudinal clinical\u002Ffunctional data and treatment exposure information (type, start, discontinuation)","From treatment initiation (or baseline if already treated) up to 12 months and end of follow-up (maximum: 31 December 2025)",{"measure":23,"description":24,"timeFrame":17},"Overall survival","Time from baseline to death from any cause.",{"measure":26,"description":27,"timeFrame":17},"Transplant-free survival","Time from baseline to lung transplantation or death.",{"measure":29,"description":30,"timeFrame":17},"Time to first progression or AE-IPF event","Time from baseline to first occurrence of disease progression or AE-IPF.",null,{"allocation":31,"interventionModel":31,"interventionModelDescription":31,"primaryPurpose":31,"observationalModel":33,"timePerspective":34,"maskingInfo":31},"COHORT","RETROSPECTIVE","OPEN-IPF addresses the current limitation of AI\u002FML research in IPF-namely, the lack of large multicentre real-world datasets with harmonised variables and robust external validation. The study will retrospectively include adult patients with IPF followed in routine practice in participating Italian referral centres from 1 January 2015 to 31 December 2025 (data lock). No study-specific procedures will be performed. De-identified\u002Fpseudonymised data will be collected using a common data model, including demographics, smoking history, comorbidities, pulmonary function (FVC, DLCO), oxygen requirement, 6-minute walk test (where available), antifibrotic treatment exposure, HRCT features routinely reported, basic laboratory parameters, and clinical outcomes. The primary modelling targets are disease progression, acute exacerbations of IPF (AE-IPF), and real-world response to antifibrotic treatment. Model development will be performed using multicentre data with explicit external validation across centres","Adults with idiopathic pulmonary fibrosis diagnosed according to international guidelines and local multidisciplinary team assessment, followed in routine care at participating Italian referral centres.",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":31,"email":42},"Roberto Tonelli, MD, PhD","CONTACT","0039059425934","rtonelli@unimore.it",{"name":44,"role":40,"phone":45,"phoneExt":31,"email":46},"Stefania Cerri, MD, PhD","00390594225335","stefania.cerri@unimore.it",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Roberto Tonelli","MD, PhD","100624037",false,"NCT07404423","OPEN-IPF: Observational Prediction modEl for cliNical Outcomes in Idiopathic Pulmonary Fibrosis","Observational Prediction Model for Clinical Outcomes in Idiopathic Pulmonary Fibrosis: a Multicentre, ML-driven Study (OPEN-IPF)","OPEN-IPF","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of idiopathic pulmonary fibrosis established according to international guidelines and local multidisciplinary team (MDT) assessment\n* Availability of baseline clinical and functional data\n* Availability of follow-up data for at least 12 months, or until a clinically relevant event (e.g., death, lung transplantation)\n\nExclusion Criteria:\n\n* Interstitial lung disease other than IPF\n* Lung transplantation performed before the baseline (index) date\n* Absence of any follow-up information after baseline","ALL","18 Years","90 Years",{"count":62,"type":63},1000,"ESTIMATED","OBSERVATIONAL","Idiopathic pulmonary fibrosis (IPF) is a progressive fibrotic lung disease with marked inter-individual heterogeneity in trajectories and outcomes. Despite antifibrotic therapies, reliable risk stratification in routine practice remains suboptimal. OPEN-IPF is a multicentre retrospective observational cohort study designed to build a harmonised real-world dataset across Italian IPF referral centres to enable the development and external validation of machine-learning (ML) models predicting clinically relevant outcomes.",[67],"Idiopathic Pulmonary Fibrosis",[69,70,71,72,73,74,75,76,77,78,79,80],"Idiopathic pulmonary fibrosis","IPF","Disease progression","Acute exacerbation","Antifibrotic therapy","Nintedanib","Pirfenidone","Real-world data","Machine learning","Prognostic model","External validation","Multicentre cohort","NOT_YET_RECRUITING","2026-02-04",{"date":84,"type":85},"2026-02-11","ACTUAL",{"date":87,"type":63},"2026-06-01",{"date":89,"type":63},"2027-06-01",{"name":5,"class":6}]