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

NCT07404423 | Not Yet Recruiting

• 1 other identifier: UModenaReggio20262
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic pulmonary fibrosis; IPF; Disease progression; Acute exacerbation; Antifibrotic therapy; Nintedanib; Pirfenidone; Real-world data; Machine learning; Prognostic model; External validation; Multicentre cohort

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (5)

• Acute exacerbation of IPF (AE-IPF)

  From baseline to end of follow-up (maximum: 31 December 2025)

• Real-world response to antifibrotic therapy

  From treatment initiation (or baseline if already treated) up to 12 months and end of follow-up (maximum: 31 December 2025)

• Overall survival

  From baseline to end of follow-up (maximum: 31 December 2025)

• Transplant-free survival

  From baseline to end of follow-up (maximum: 31 December 2025)

• Time to first progression or AE-IPF event

  From baseline to end of follow-up (maximum: 31 December 2025)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with idiopathic pulmonary fibrosis diagnosed according to international guidelines and local multidisciplinary team assessment, followed in routine care at participating Italian referral centres.

You may qualify if:

• 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)

You may not qualify if:

• Interstitial lung disease other than IPF
• Lung transplantation performed before the baseline (index) date
• Absence of any follow-up information after baseline

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Disease Progression

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Roberto Tonelli, MD, PhD

CONTACT

0039059425934; rtonelli@unimore.it

Stefania Cerri, MD, PhD

CONTACT

00390594225335; stefania.cerri@unimore.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02