Not Yet RecruitingNot Applicable

OPEN-IPF: Observational Prediction modEl for cliNical Outcomes in Idiopathic Pulmonary Fibrosis

1,000 participantsStarted 2026-06-01

Plain-language summary

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.

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Disease progression (guideline-based functional/composite criteria)

Timeframe: From baseline (index date) up to 12 months and up to end of available follow-up (maximum: 31 December 2025)

Trial details

NCT IDNCT07404423

SponsorUniversity of Modena and Reggio Emilia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-01-01

Contact for this trial

Roberto Tonelli, MD, PhD

0039059425934 rtonelli@unimore.it

View on ClinicalTrials.gov More Idiopathic Pulmonary Fibrosis trials