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Validation of the Risk Stratification Score in Idiopathic Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02632123
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : December 10, 2020
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:

Idiopathic pulmonary fibrosis (IPF) is a progressing scarring disease of the lungs with an average survival of only 30-36 months since the time of diagnosis, in the absence of treatment. The clinical course of IPF is highly variable, with some patients remaining stable for a prolonged period of time, even in the absence of medical treatment, while others experience rapid and relentless progression. In some cases, the clinical course consists of a stepwise rather than steady decline, with periods of stability alternating with acute respiratory worsening. The variability in clinical course makes it challenging to define prognosis in these patients and, importantly, to determine the right time window for lung transplantation (LTx) referral, listing and priority status on the waiting list.

The risk stratification score (RISE) is a new, multi-dimensional staging system for IPF based on the MRC dyspnea score, on physiology variables (pulmonary function tests) captured in the Composite Physiologic Index (CPI), and on the 6-minute walk distance. RISE showed to predict survival in newly diagnosed patients with IPF better than any other individual clinical, functional or radiographic variable. RISE also predicted survival on the waiting list in patients assessed and listed for LTx. The objective of this study is to validate this staging system in a large cohort of patients newly diagnosed with IPF and followed for at least 3 years.

Condition or disease
Idiopathic Pulmonary Fibrosis

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the Risk Stratification Score in Idiopathic Pulmonary Fibrosis
Actual Study Start Date : December 2015
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Idiopathic pulmonary fibrosis
Patients newly diagnosed with idiopathic pulmonary fibrosis

Primary Outcome Measures :
  1. Survival [ Time Frame: 3 years ]
    Primary outcome is 3-year survival since the time of diagnosis

Secondary Outcome Measures :
  1. Acute exacerbation of IPF [ Time Frame: 3 years ]
    Secondary outcome is the incidence of acute exacerbations since the time of diagnosis

  2. Clinical progression [ Time Frame: 3 years ]
    Time to either: decline of FVC >10% pred; decline of 6-min walk distance >50 m; hospitalization for respiratory causes; lung transplant assessment; or death.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients newly diagnosed with idiopathic pulmonary fibrosis.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02632123

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Contact: Marco Mura, MD, PhD +1-5196676744

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Canada, Ontario
London Health Science Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Marco Mura, MD, PhD    +15196676744   
Contact: Mena Gaed, MBCCh, MSc    +15196858500 ext 73451   
Principal Investigator: Marco Mura, MD, PhD         
Sponsors and Collaborators
Lawson Health Research Institute
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Responsible Party: Lawson Health Research Institute Identifier: NCT02632123    
Other Study ID Numbers: 10010803
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: June 2020
Keywords provided by Lawson Health Research Institute:
idiopathic pulmonary fibrosis
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial