Validation of the Risk Stratification Score in Idiopathic Pulmonary Fibrosis

NCT02632123 | Completed

• 1 other identifier: 10010803
• Study Type: observational
• Target: 260
• Locations: 2 countries
• Sites: 2

Brief Summary

Idiopathic pulmonary fibrosis (IPF) is characterized by a poor prognosis, with a progressive decline in lung function and a considerable variability in the disease's natural history. Besides lung transplantation (LTx), the only available treatments are anti-fibrosing drugs, which have shown to slower the disease course. Therefore, predicting the prognosis is of pivotal importance to avoid treatment delays, which may be fatal for patients with a high risk of progression. Previous studies showed that a multi-dimensional approach is practical and effective to create a reliable prognostic score for IPF. In the RIsk Stratification scorE (RISE), physiological parameters, an objective measure of patient-reported dyspnea and exercise capacity are combined to capture different domains of the complex pathophysiology of IPF. This is an observational, multi-centre, prospective cohort study. A development cohort and a validation cohort will be included. Patients newly diagnosed with IPF based on the ATS/ERS criteria and multi-disciplinary discussion will be included in the study. A panel of chest radiologists and lung pathologists will further assess eligibility. At the first visit (time of diagnosis), and every 4-months, MRCDS, pulmonary function tests (FEV1, FVC and DLCO), and 6MWD will be recorded and patients will be prospectively followed for 3 years. Comorbidities will be considered. The radiographic extent of fibrosis on HRCT will be recalculated at a 2-year interval. RISE, Gender-Age-Physiology, CPI and Mortality Risk Scoring System will be calculated at 4-month intervals. Longitudinal changes of each variable considered will be assessed. The primary endpoint is 3-year LTx-free survival from the time of diagnosis. Secondary endpoints include several, clinically-relevant information to ensure reproducibility of results across a wide range of disease severity and in concomitance of associated pulmonary hypertension, emphysema. The present study aims at validating RISE as a simple, straightforward, inexpensive and reproducible tool to guide clinical decision making in IPF and potentially as an endpoint for future clinical trials.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

idiopathic pulmonary fibrosis; outcome; prognosis; survival; staging

Outcome Measures

Primary Outcomes (1)

• Survival

  Primary outcome is lung-transplant-free 3-year survival since the time of diagnosis

  3 years

Secondary Outcomes (13)

• Subgroup analysis

  3 years

• Clinical progression

  3 years

• Incidence of acute exacerbations

  3 years

• Incidence of hospitalizations

  3 years

• Results stratification by HRT pattern

  3 years

Study Arms (2)

Development cohort

Patients newly diagnosed with idiopathic pulmonary fibrosis

Validation cohort

Patients newly diagnosed with idiopathic pulmonary fibrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients newly diagnosed with idiopathic pulmonary fibrosis.

You may qualify if:

• A new diagnosis of IPF based on the American Thoracic Society/European Respiratory Society criteria (Am J Respir Crit Care Med 2018;198:e44-e68) and confirmed by a panel of expert chest radiologists and lung pathologists in the context of multi-disciplinary discussion.

You may not qualify if:

• Interstitial lung disease other than IPF
• Not a new diagnosis of IPF

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Western University, Canada: collaborator
• University of Rome Tor Vergata: collaborator
• University of Waterloo: collaborator

Study Sites (2)

London Health Science Centre

London, Ontario, N6A 5W9, Canada

Location

Policlinico Tor Vergata

Rome, Lazio, 00133, Italy

Location

Related Publications (50)

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  PMID: 34863146 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2015
• First Posted: December 16, 2015
• Study Start: December 1, 2015
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

IT (1); CA (1)