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Trial record 1 of 1 for:    NCT03670576
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It's Not JUST Idiopathic Pulmonary Fibrosis Study (INJUSTIS)

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ClinicalTrials.gov Identifier: NCT03670576
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
Nottingham University Hospitals NHS Trust
Information provided by (Responsible Party):
University of Nottingham

Tracking Information
First Submitted Date August 6, 2018
First Posted Date September 13, 2018
Last Update Posted Date September 13, 2018
Actual Study Start Date July 11, 2018
Estimated Primary Completion Date July 11, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 12, 2018)
  • Disease Progression [ Time Frame: Within 12 months ]
    Defined as >10% relative decline in FVC and mortality at 12 months
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 12, 2018)
Serum and Plasma Biomarkers [ Time Frame: Baseline, 3 months, 12 months, 24 months ]
SPD, MUC16, CA199, Nordic Neoepitopes
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 12, 2018)
  • DLco [ Time Frame: Baseline, 3 months, 12 months, 24 months ]
    Diffusing Capacity of the Lung for Carbon Monoxide
  • Quality of Life Questionnaires [ Time Frame: Baseline, 3 months, 12 months, 24 months. ]
    Assessment of how the patients well-being may be affected over time by their interstitial lung disease
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title It's Not JUST Idiopathic Pulmonary Fibrosis Study
Official Title It's Not JUST Idiopathic Pulmonary Fibrosis Study
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood (Serum, Plasma) Bronchoscopy Biopsy Samples (Optional)
Sampling Method Probability Sample
Study Population Participants will be recruited from ILD and IPF clinics.
Condition
  • Interstitial Lung Disease
  • Idiopathic Pulmonary Fibrosis
Intervention
  • Procedure: Optional Bronchoscopy
    Patients can decide to have an optional bronchoscopy so that samples can be taken for research up to three months from baseline.
  • Other: Quality of Life Questionnaires
    MRC Dyspnoea, SPARC, KBILD and EQ-5D-5L will be administered at baseline, 3 months, 12 months and 24 months,
  • Other: Blood Samples for Biomarkers
    a 40ml research blood sample to be taken at baseline, 3 months, 12 months and 24 months.
Study Groups/Cohorts
  • Case
    A diagnosis of Fibrotic Lung disease classified in 4 categories, RA-UIP, Asbestosis, Chronic HP and Unclassifiable as agreed by an ILD MDT consensus panel.
    Interventions:
    • Procedure: Optional Bronchoscopy
    • Other: Quality of Life Questionnaires
    • Other: Blood Samples for Biomarkers
  • Control
    Positive control will be frequency matched to cases of ILD and will be people in secondary care who have an MDT diagnosis of Definite IPF.
    Interventions:
    • Procedure: Optional Bronchoscopy
    • Other: Quality of Life Questionnaires
    • Other: Blood Samples for Biomarkers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 12, 2018)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 11, 2022
Estimated Primary Completion Date July 11, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Case Cohort

Inclusion Criteria:

  • An MDT diagnosis of Fibrotic Lung Disease classified as either RA-UIP, Asbestosis, Chronic HP or Unclassifiable Fibrotic Lung Disease
  • Male or female aged >18 years
  • Ability to give informed consent

Control Cohort

Inclusion Criteria:

  • An MDT diagnosis of definite Idiopathic Pulmonary Fibrosis
  • Male or female aged >18 years
  • Ability to give informed consent

Exclusion Criteria:

  • People who do not have ILD
  • People who cannot give informed consent
  • People who have contraindications to bronchoscopy can still take part in the study as this procedure is optional.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03670576
Other Study ID Numbers 18014
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University of Nottingham
Study Sponsor University of Nottingham
Collaborators Nottingham University Hospitals NHS Trust
Investigators Not Provided
PRS Account University of Nottingham
Verification Date September 2018