An observational study in Idiopathic Pulmonary Fibrosis, sponsored by University of Modena and Reggio Emilia. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by University of Modena and Reggio Emilia · 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.
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
576 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 123 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 152 across 165 observational studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →University of Modena and Reggio Emilia is the lead sponsor of 65 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with idiopathic pulmonary fibrosis diagnosed according to international guidelines and local multidisciplinary team assessment, followed in routine care at participating Italian referral centres.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Disease progression (guideline-based functional/composite criteria)
Disease progression defined using guideline-based criteria derived from routinely collected clinical data (e.g., decline in lung function and/or composite progression definitions as per the shared operational document).
Time frame: From baseline (index date) up to 12 months and up to end of available follow-up (maximum: 31 December 2025)
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.
Time frame: From baseline to end of follow-up (maximum: 31 December 2025)
Real-world response to antifibrotic therapy
Treatment response assessed in routine clinical practice using longitudinal clinical/functional data and treatment exposure information (type, start, discontinuation)
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 from baseline to death from any cause.
Time frame: From baseline to end of follow-up (maximum: 31 December 2025)
Transplant-free survival
Time from baseline to lung transplantation or death.
Time frame: From baseline to end of follow-up (maximum: 31 December 2025)
Time to first progression or AE-IPF event
Time from baseline to first occurrence of disease progression or AE-IPF.
Time frame: From baseline to end of follow-up (maximum: 31 December 2025)
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Jan 2027, 7 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Idiopathic Pulmonary Fibrosis →
University of Modena and Reggio Emilia