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IPF Longitudinal Natural History Study

2026年4月24日 更新者：Ahmad Shaddad、Assiut University

Natural History and Temporal Dynamics of Idiopathic Pulmonary Fibrosis: A Longitudinal Cohort Study With Structured Disease Stratification

This is a longitudinal observational cohort study of patients with idiopathic pulmonary fibrosis (IPF) conducted within the Assiut University IPF Research Program between 2022 and 2026. The study aims to characterize the natural history, temporal disease dynamics, event patterns, and clinical outcomes of IPF over a two-year follow-up period.

Primary analyses focus on disease progression, acute exacerbation, hospitalization, mortality, and final clinical state. Secondary analyses include prespecified evaluation of the Inflammatory Burnout Index (IBI; Zenodo DOI: 10.5281/zenodo.18843181) and the Severity-Phenotype-Dynamics integration framework (SPD; Zenodo DOI: 10.5281/zenodo.18843362) as observational analytical frameworks for disease activity and multidimensional disease characterization. These frameworks are applied for research stratification only and do not influence treatment allocation, clinical management, or follow-up decisions.

研究概览

地位

主动，不招人

条件

详细说明

This observational cohort study follows patients with idiopathic pulmonary fibrosis using predefined longitudinal clinical, physiological, radiological, and outcome assessments. The study is designed to describe disease burden, temporal progression, event distribution, and end-state outcomes in a real-world IPF cohort.

Eligible participants are adults with a clinical and radiological diagnosis of IPF according to standard diagnostic assessment, with available baseline evaluation and planned longitudinal follow-up. Patients are followed for up to two years to document acute exacerbations, respiratory hospitalization, functional decline, mortality, and final clinical status.

The study includes secondary analytical evaluation of two predefined disease-characterization frameworks. The Inflammatory Burnout Index (IBI) is used to evaluate dynamic inflammatory-fibrotic balance and functional reserve. The SPD framework integrates disease severity, phenotype, and dynamic disease behavior into a multidimensional observational stratification structure. Both frameworks are archived with Zenodo DOIs and are evaluated without modifying patient care.

研究类型

观察性的

注册 (实际的)

1423

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 埃及
      • Asyut、埃及、71515
        • Faculty Of Medicine - Assiut University Hospitals - Assiut - Egypt

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult patients diagnosed with idiopathic pulmonary fibrosis enrolled in a longitudinal observational cohort at Assiut University between 2022 and 2026. Participants undergo standardized baseline evaluation and structured follow-up to document disease progression, acute exacerbations, hospitalization, and mortality. The cohort represents real-world clinical practice and includes patients eligible for longitudinal assessment without intervention assignment.

描述

Inclusion Criteria:

  • Adults aged ≥18 years.
  • Diagnosis of idiopathic pulmonary fibrosis based on clinical and radiological assessment according to standard guidelines.
  • Availability of baseline clinical, functional, and radiological evaluation.
  • Enrollment within the Assiut University IPF Research Program.
  • Ability to undergo longitudinal follow-up and outcome assessment.

Exclusion Criteria:

  • Interstitial lung disease other than idiopathic pulmonary fibrosis
  • Alternative diagnosis inconsistent with IPF based on clinical or radiological evaluation
  • Incomplete baseline data preventing cohort classification
  • Refusal to participate or inability to complete follow-up
  • End-stage disease at baseline requiring invasive mechanical ventilation or terminal care
  • Active malignancy or severe comorbidity expected to dominate short-term prognosis
  • Long-term systemic immunosuppressive therapy not aligned with standard IPF management

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Idiopathic Pulmonary Fibrosis Cohort
This cohort includes adult patients with idiopathic pulmonary fibrosis enrolled in a longitudinal observational study conducted between 2022 and 2026 at Assiut University. Participants undergo predefined follow-up assessments to document clinical outcomes, including disease progression, acute exacerbations, hospitalization, and mortality. No interventions are assigned, and all data are collected as part of routine clinical care and structured observational follow-up.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Time to First Composite Clinical Event (Acute Exacerbation, Hospitalization, or Death) in 24 months
大体时间：24 months
Time from cohort entry (baseline enrollment) to the first occurrence of any of the following events: acute exacerbation of idiopathic pulmonary fibrosis, respiratory-related hospitalization, or all-cause mortality. Events are prospectively recorded during longitudinal follow-up within the study period.
24 months

次要结果测量

结果测量
措施说明
大体时间
Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis
大体时间：Up to 24 months
Time from baseline enrollment to the first occurrence of acute exacerbation of idiopathic pulmonary fibrosis during follow-up.
Up to 24 months
Time to First Respiratory-Related Hospitalization
大体时间：Up to 24 months
Time from baseline to first hospitalization related to respiratory deterioration or acute exacerbation.
Up to 24 months
All-Cause Mortality
大体时间：Up to 24 months
Occurrence of death from any cause during the study follow-up period.
Up to 24 months
Inflammatory Burnout Index (IBI)-Defined Disease Activity
大体时间：Up to 12 months
Evaluation of disease activity using the Inflammatory Burnout Index (IBI), a predefined analytical framework for dynamic disease characterization (Zenodo DOI: 10.5281/zenodo.18843181). Applied observationally without influencing clinical management.
Up to 12 months
Severity-Phenotype-Dynamics (SPD) Integrated Disease States
大体时间：Up to 24 months
Assessment of integrated disease states using the Severity-Phenotype-Dynamics (SPD) framework combining severity, phenotype, and dynamic disease behavior (Zenodo DOI: 10.5281/zenodo.18843362). Applied for observational stratification only.
Up to 24 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Assiut University

调查人员

  • 首席研究员：Aliae A. Hussien, MD、Assiut University
  • 首席研究员：Ahmad M. Shaddad, MD、Assiut University
  • 首席研究员：Maiada K. Hashem, MD、Assiut University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年4月1日

初级完成 (估计的)

2026年8月1日

研究完成 (估计的)

2026年9月1日

研究注册日期

首次提交

2026年4月24日

首先提交符合 QC 标准的

2026年4月24日

首次发布 (实际的)

2026年5月1日

研究记录更新

最后更新发布 (实际的)

2026年5月1日

上次提交的符合 QC 标准的更新

2026年4月24日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2025-23-4

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data underlying the results reported in this study will not be publicly shared. Data are governed by the Assiut University IPF Research Program policies and institutional regulations. De-identified data may be considered for sharing upon reasonable request to the corresponding investigator, subject to institutional review, ethical approval, and execution of a formal data use agreement.

Analytical code and model specifications are not publicly distributed. Access may be considered under controlled conditions in accordance with institutional policy, intellectual property considerations, and approved collaborative agreements.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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