OPEN-IPF: Observational Prediction modEl for cliNical Outcomes in Idiopathic Pulmonary Fibrosis
- Sponsor
- University of Modena and Reggio Emilia
- Study ID
- NCT07404423
- Status
- Not Yet Recruiting
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Conditions
- Idiopathic Pulmonary Fibrosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- First listed
- Feb 11, 2026
- Start date
- Jun 1, 2026
- Status verified
- Feb 2026
- Primary completion
- Jan 1, 2027
- Completion
- Jun 1, 2027
Study Design
- Enrollment
- 1,000 participants (estimated)
Primary Outcome Measure
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) ]
Central Contacts
- Roberto Tonelli, MD, PhD0039059425934
- Stefania Cerri, MD, PhD00390594225335
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