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

NCT01134822 | Completed

• 1 other identifier: 09116
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; IPF; Lung Fibrosis; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Discover biomarkers in IPF

  * 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 Outcomes (1)

• Survival from Pulmonary fibrosis.

  10 years

Study Arms (1)

Idiopathic pulmonary fibrosis (IPF)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be recruited from IPF clinics

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• Medical Research Council: collaborator
• GlaxoSmithKline: collaborator
• CRAFT Consortium: collaborator
• McMaster University: collaborator

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

Related Publications (4)

• Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.

  PMID: 35688625 DERIVED

• Clynick B, Corte TJ, Jo HE, Stewart I, Glaspole IN, Grainge C, Maher TM, Navaratnam V, Hubbard R, Hopkins PMA, Reynolds PN, Chapman S, Zappala C, Keir GJ, Cooper WA, Mahar AM, Ellis S, Goh NS, De Jong E, Cha L, Tan DBA, Leigh L, Oldmeadow C, Walters EH, Jenkins RG, Moodley Y. Biomarker signatures for progressive idiopathic pulmonary fibrosis. Eur Respir J. 2022 Mar 31;59(3):2101181. doi: 10.1183/13993003.01181-2021. Print 2022 Mar.

  PMID: 34675050 DERIVED

• Maher TM, Oballa E, Simpson JK, Porte J, Habgood A, Fahy WA, Flynn A, Molyneaux PL, Braybrooke R, Divyateja H, Parfrey H, Rassl D, Russell AM, Saini G, Renzoni EA, Duggan AM, Hubbard R, Wells AU, Lukey PT, Marshall RP, Jenkins RG. An epithelial biomarker signature for idiopathic pulmonary fibrosis: an analysis from the multicentre PROFILE cohort study. Lancet Respir Med. 2017 Dec;5(12):946-955. doi: 10.1016/S2213-2600(17)30430-7. Epub 2017 Nov 14.

  PMID: 29150411 DERIVED

• Jenkins RG, Simpson JK, Saini G, Bentley JH, Russell AM, Braybrooke R, Molyneaux PL, McKeever TM, Wells AU, Flynn A, Hubbard RB, Leeming DJ, Marshall RP, Karsdal MA, Lukey PT, Maher TM. Longitudinal change in collagen degradation biomarkers in idiopathic pulmonary fibrosis: an analysis from the prospective, multicentre PROFILE study. Lancet Respir Med. 2015 Jun;3(6):462-72. doi: 10.1016/S2213-2600(15)00048-X. Epub 2015 Mar 12.

  PMID: 25770676 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood(serum, plasma) \& Lavage Fluid

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gisli Jenkins, Dr

  University of Nottingham

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 2, 2010
• Study Start: July 1, 2010
• Primary Completion: September 5, 2017
• Study Completion: September 5, 2017
• Last Updated: October 15, 2018

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)