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

October 10, 2018 updated by: University of Nottingham
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants will be recruited from IPF clinics

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Idiopathic pulmonary fibrosis (IPF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

GlaxoSmithKline
McMaster University
Medical Research Council
CRAFT Consortium

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

September 5, 2017

Study Completion (ACTUAL)

September 5, 2017

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

June 1, 2010

First Posted (ESTIMATE)

June 2, 2010

Study Record Updates

Last Update Posted (ACTUAL)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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