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Clinical Trials/NCT03670576
NCT03670576UnknownNot Applicable

It's Not JUST Idiopathic Pulmonary Fibrosis Study

University of Nottingham24 sites in 1 country250 target enrollmentStarted: November 11, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
250
Locations
24
Primary Endpoint
Overall Survival
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Study of progression of fibrosis in ILD

Detailed Description

The overall aims of this study are

  • Identify biomarkers and gene expression profiles that determine progressive fibrotic lung disease regardless of aetiology
  • To prospectively assess biomarkers which predict progressive fibrosis in patients with fibrosing lung disease of alternate aetiology, including RA-UIP, Asbestosis, Chronic Hypersensitivity Pneumonitis and Unclassifiable fibrotic lung disease
  • Investigate genetic associations and epigenetic modifications which affect fibrotic disease severity and progression
  • Prospectively evaluate longitudinal disease behaviour in patients with non IPF-fibrotic lung diseases with a view to developing composite clinical end-points for subsequent use in intervention studies in patients

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • •Participating in an interventional clinic trial
  • •Asymptomatic Interstitial Lung Abnormalities (ILA) and normal lung function.
  • •Change in clinical phenotype from initial radiological diagnosis to screening
  • •Acute Hypersensitivity Pneumonitis.
  • •Participants who do not possess a smartphone or have a valid email address (necessary for the home FVC readings)

Outcomes

Primary Outcomes

Overall Survival

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.

Disease Progression

Time Frame: Within 12 months

Disease progression defined as \>10% relative decline in FVC (using either hospital spirometry or home hand held spirometry) or death within 12 months.

Secondary Outcomes

  • Serum and Plasma Biomarkers(Baseline, 3 months, 12 months, 24 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (24)

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