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

Официальное название

Observational Prediction Model for Clinical Outcomes in Idiopathic Pulmonary Fibrosis: a Multicentre, ML-driven Study (OPEN-IPF)

Обзор

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.

Подробное описание

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

Первичные конечные точки

• Disease progression (guideline-based functional/composite criteria) [Срок оценки: From baseline (index date) up to 12 months and up to end of available follow-up (maximum: 31 December 2025)]

Вторичные конечные точки (5)

• Acute exacerbation of IPF (AE-IPF) [Срок оценки: From baseline to end of follow-up (maximum: 31 December 2025)]
• Real-world response to antifibrotic therapy [Срок оценки: From treatment initiation (or baseline if already treated) up to 12 months and end of follow-up (maximum: 31 December 2025)]
• Overall survival [Срок оценки: From baseline to end of follow-up (maximum: 31 December 2025)]
• Transplant-free survival [Срок оценки: From baseline to end of follow-up (maximum: 31 December 2025)]
• Time to first progression or AE-IPF event [Срок оценки: From baseline to end of follow-up (maximum: 31 December 2025)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07404423 · UModenaReggio20262

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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