Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study (PROFILE)
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|ClinicalTrials.gov Identifier: NCT01110694|
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : March 27, 2019
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|Condition or disease|
|Idiopathic Pulmonary Fibrosis Idiopathic Non-specific Interstitial Pneumonitis|
|Study Type :||Observational|
|Actual Enrollment :||230 participants|
|Official Title:||Prospective Observation of Fibrosis in the Lung Clinical Endpoints (PROFILE_Brompton)Study|
|Actual Study Start Date :||September 2010|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
- Biomarker discovery [ Time Frame: 3 years ]Discover and validate novel biomarkers and gene expression profiles for use in subsequent clinical studies in patients with idiopathic pulmonary fibrosis.
- Study disease behaviour [ Time Frame: 3 years ]Prospectively evaluate longitudinal disease behavior in patients with IPF and other fibrotic lung diseases of unknown cause with a view to developing composite clinical endpoints for subsequent use in clinical studies in patients with pulmonary fibrosis.
- Differentiate IPF from NSIP [ Time Frame: 3 years ]Identify differences in the pathogenetic mechanisms involved in the development of different types of fibrosis in patients with fibrotic lung disease of unknown cause.
Biospecimen Retention: Samples With DNA
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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|
- Individuals over the age of 18 with a diagnosis of definite or probable IPF or definite or probable fibrotic NSIP as defined by the ATS/ERS consensus classification
- Patients with co-existent conditions known to be associated with the development of fibrotic lung disease will be excluded.
- connective tissue disease
- suspected drug-induced lung disease
- asbestosis or other asbestos related disease (pleural plaques, mesothelioma, asbestos pleural effusions)
- granulomatous disease including sarcoidosis.
- Patients with an auto-immune profile considered diagnostic for a specific connective tissue disease will be excluded, even in the absence of systemic symptoms.
- Non-specific rises in auto antibodies e.g. rheumatoid factor, anti-nuclear antibody etc. will not be used to exclude individuals from the study.
- Patients with co-morbid disease that in the opinion of the investigators gives them an expected life expectancy of less than one year will be excluded from the study.
- Patients involved in clinical trials assessing novel IPF therapies will be excluded from enrolment in this study.
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 ClinicalTrials.gov identifier (NCT number): NCT01110694
|Royal Brompton Hospital|
|London, United Kingdom, SW3 6NP|
|Principal Investigator:||Toby M Maher, MB PhD||Royal Brompton and Harefield Foundation NHS Trust|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Royal Brompton & Harefield NHS Foundation Trust|
|Other Study ID Numbers:||
10/H0720/12 ( Other Identifier: Royal Free Hospital REC )
|First Posted:||April 27, 2010 Key Record Dates|
|Last Update Posted:||March 27, 2019|
|Last Verified:||March 2019|
Idiopathic pulmonary fibrosis
Interstitial lung disease
Idiopathic Pulmonary Fibrosis
Lung Diseases, Interstitial
Respiratory Tract Diseases
Respiratory Tract Infections