OPEN-IPF: Observational Prediction modEl for cliNical Outcomes in Idiopathic Pulmonary Fibrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Idiopathic Pulmonary Fibrosis. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Observational Prediction Model for Clinical Outcomes in Idiopathic Pulmonary Fibrosis: a Multicentre, ML-driven Study (OPEN-IPF)
Overview
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.
Detailed description
OPEN-IPF addresses the current limitation of AI/ML 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/pseudonymised 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
Primary outcome measures
- Disease progression (guideline-based functional/composite criteria) [Time frame: From baseline (index date) up to 12 months and up to end of available follow-up (maximum: 31 December 2025)]
Secondary outcome measures (5)
- Acute exacerbation of IPF (AE-IPF) [Time frame: From baseline to end of follow-up (maximum: 31 December 2025)]
- Real-world response to antifibrotic therapy [Time frame: From treatment initiation (or baseline if already treated) up to 12 months and end of follow-up (maximum: 31 December 2025)]
- Overall survival [Time frame: From baseline to end of follow-up (maximum: 31 December 2025)]
- Transplant-free survival [Time frame: From baseline to end of follow-up (maximum: 31 December 2025)]
- Time to first progression or AE-IPF event [Time frame: From baseline to end of follow-up (maximum: 31 December 2025)]
Eligibility criteria
Inclusion criteria
- Age ≥18 years
- Diagnosis of idiopathic pulmonary fibrosis established according to international guidelines and local multidisciplinary team (MDT) assessment
- Availability of baseline clinical and functional data
- Availability of follow-up data for at least 12 months, or until a clinically relevant event (e.g., death, lung transplantation)
Exclusion criteria
- Interstitial lung disease other than IPF
- Lung transplantation performed before the baseline (index) date
- Absence of any follow-up information after baseline
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07404423 · UModenaReggio20262