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Prospective Study of Fibrosis In the Lung Endpoints (PROFILE - Central England) (PROFILE)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01134822
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
Medical Research Council
GlaxoSmithKline
CRAFT Consortium
McMaster University
Information provided by (Responsible Party):
University of Nottingham

Study Description
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Brief Summary:
The overall aim of this study is to develop a test that predicts the prognosis of IPF (Idiopathic Pulmonary Fibrosis) and which could be used to determine whether new treatments for IPF are likely to work.

Condition or disease
Idiopathic Pulmonary Fibrosis

Detailed Description:

The overall objectives of this study are

  • Discover and validate novel biomarkers and gene expression profiles for use in subsequent intervention studies in patients with IPF
  • To prospectively validate a panel of previously published biomarkers in patients with well characterized idiopathic fibrosing lung disease
  • Investigate genetic associations and epigenetic modifications which affect disease severity and progression
  • Prospectively evaluate longitudinal disease behaviour in patients with IPF and NSIP with a view to developing composite clinical end-points for subsequent use in intervention studies in patients with IPF

Biomarkers that can be used for the following purposes will be identified:

  • Identify patients (Diagnostic)(e.g. discriminate between health and disease)
  • Correlate with disease severity (extent of disease, staging of disease)
  • Predict clinical progression (Prognostic)(stable vs progressive disease)
  • Track response to therapy (Therapeutic response)- Predict response to known efficacious treatments & Correlates with changes in clinical endpoints/mortality/quality of life
  • Predict risk of exacerbations (could be used to prevent exacerbations or reduce their severity)
  • Correlate with complications and/or comorbidities (e.g. biomarkers of Pulmonary Arterial Hypertension, Gastro Oesophageal Reflux in IPF, etc)
Study Design
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Study Type : Observational
Actual Enrollment : 330 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study of Fibrosis In the Lung Endpoints (PROFILE - Central England)
Study Start Date : July 2010
Actual Primary Completion Date : September 5, 2017
Actual Study Completion Date : September 5, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Idiopathic pulmonary fibrosis (IPF)


Outcome Measures
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Primary Outcome Measures :
  1. Discover biomarkers in IPF [ Time Frame: 36 months ]
    • Discover and validate novel biomarkers for use in subsequent intervention studies in patients with IPF
    • To prospectively validate a panel of previously published biomarkers in patients with well characterized idiopathic fibrosing lung disease
    • Investigate genetic associations and epigenetic modifications which affect disease severity and progression


Secondary Outcome Measures :
  1. Survival from Pulmonary fibrosis. [ Time Frame: 10 years ]
    All patients will be tagged at the central NHS registry in order to provide mortality data. For this reason we will need to keep our datasets active for up to 10 years to allow a complete mortality analysis.


Biospecimen Retention:   Samples With DNA
Blood(serum, plasma) & Lavage Fluid

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants will be recruited from IPF clinics
Criteria

Inclusion Criteria:

A diagnosis of IPF using the consensus criteria (32)and Non Specific Interstitial Pneumonia.

  • Between the age group 18-85 years.
  • Sub classified into Mild (TLCO>60), Moderate (TLCO 40-60), Severe (TLCO<40).
  • People who volunteer to undergo a bronchoscopy for research

Exclusion Criteria:

  • People who do not have IPF/NSIP (i.e. Hypersensitivity Pneumonitis, Sarcoidosis)
  • People who cannot give informed consent.
  • People who are being considered for bronchoscopy, any contra-indication to undergoing this procedure as set out in the British Thoracic Society guidelines (Thorax 2001; 56: suppl I: i1-i21). These will be part of the study but not undergo the Broncho Alveolar Lavage.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01134822


Locations
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United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
University of Nottingham
Medical Research Council
GlaxoSmithKline
CRAFT Consortium
McMaster University
Investigators
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Study Director: Gisli Jenkins, Dr University of Nottingham
Principal Investigator: Robert Berg, Dr University Hospitals of Derby and Burton NHS Foundation Trust
Principal Investigator: Sanjay Agarwal, Dr University Hospitals, Leicester
Principal Investigator: Moira White, Dr Sheffield Teaching Hospitals NHS Foundation Trust
Principal Investigator: Khaled Amsha, Dr Sherwood Forest Hospitals NHS Trust
Principal Investigator: David Thickett, Dr University Hospital Birmingham NHS Foundation Trust
Principal Investigator: Uttam Nanda, Dr Burton Hospitals NHS Foundation Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01134822    
Other Study ID Numbers: 09116
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Nottingham:
Idiopathic Pulmonary Fibrosis
IPF
Lung Fibrosis
Biomarkers
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases