IPF Longitudinal Natural History Study
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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Asyut, Egipt, 71515
- Faculty Of Medicine - Assiut University Hospitals - Assiut - Egypt
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Time to First Composite Clinical Event (Acute Exacerbation, Hospitalization, or Death) in 24 months
Ramy czasowe: 24 months
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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.
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24 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Ramy czasowe: Up to 24 months
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Time from baseline enrollment to the first occurrence of acute exacerbation of idiopathic pulmonary fibrosis during follow-up.
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Up to 24 months
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Time to First Respiratory-Related Hospitalization
Ramy czasowe: Up to 24 months
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Time from baseline to first hospitalization related to respiratory deterioration or acute exacerbation.
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Up to 24 months
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All-Cause Mortality
Ramy czasowe: Up to 24 months
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Occurrence of death from any cause during the study follow-up period.
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Up to 24 months
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Inflammatory Burnout Index (IBI)-Defined Disease Activity
Ramy czasowe: Up to 12 months
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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.
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Up to 12 months
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Severity-Phenotype-Dynamics (SPD) Integrated Disease States
Ramy czasowe: Up to 24 months
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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.
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Up to 24 months
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Aliae A. Hussien, MD, Assiut University
- Główny śledczy: Ahmad M. Shaddad, MD, Assiut University
- Główny śledczy: Maiada K. Hashem, MD, Assiut University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2025-23-4
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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