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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
-
Asyut, Ägypten, 71515
- Faculty Of Medicine - Assiut University Hospitals - Assiut - Egypt
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Time to First Composite Clinical Event (Acute Exacerbation, Hospitalization, or Death) in 24 months
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Zeitfenster: 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
Zeitfenster: Up to 24 months
|
Time from baseline to first hospitalization related to respiratory deterioration or acute exacerbation.
|
Up to 24 months
|
|
All-Cause Mortality
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Aliae A. Hussien, MD, Assiut University
- Hauptermittler: Ahmad M. Shaddad, MD, Assiut University
- Hauptermittler: Maiada K. Hashem, MD, Assiut University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025-23-4
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .