Clinical trial NCT01134822: Prospective Study of Fibrosis In the Lung Endpoints (PROFILE - Central England)
Official title: Prospective Study of Fibrosis In the Lung Endpoints (PROFILE - Central England)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic Pulmonary Fibrosis
IPF
Lung Fibrosis
Biomarkers
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: GlaxoSmithKline
name: CRAFT Consortium
name: McMaster University
First posted: 2010-06-02
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from IPF clinics

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.

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)

Eligibility 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.

Primary outcomes:
measure: Discover biomarkers in IPF
timeFrame: 36 months
Secondary outcomes:
measure: Survival from Pulmonary fibrosis.
timeFrame: 10 years
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: University of Nottingham
name: Gisli Jenkins, Dr
role: STUDY_DIRECTOR
affiliation: University Hospitals of Derby and Burton NHS Foundation Trust
name: Robert Berg, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals, Leicester
name: Sanjay Agarwal, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Moira White, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Sherwood Forest Hospitals NHS Trust
name: Khaled Amsha, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Birmingham NHS Foundation Trust
name: David Thickett, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Burton Hospitals NHS Foundation Trust
name: Uttam Nanda, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.