Observational Prediction Model for Clinical Outcomes in Idiopathic Pulmonary Fibrosis: a Multicentre, ML-driven Study (OPEN-IPF)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 主要终点
- Disease progression (guideline-based functional/composite criteria)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Interstitial lung disease other than IPF
- •Lung transplantation performed before the baseline (index) date
- •Absence of any follow-up information after baseline
结局指标
主要结局
Disease progression (guideline-based functional/composite criteria)
时间窗: From baseline (index date) up to 12 months and up to end of available follow-up (maximum: 31 December 2025)
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).
次要结局
- 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))
研究者
Roberto Tonelli
MD, PhD
University of Modena and Reggio Emilia