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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

Brief Summary:
Study of progression of fibrosis in ILD

Condition or disease Intervention/treatment
Interstitial Lung Disease Idiopathic Pulmonary Fibrosis Procedure: Optional Bronchoscopy Other: Quality of Life Questionnaires Other: Blood Samples for Biomarkers

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

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: It's Not JUST Idiopathic Pulmonary Fibrosis Study
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : July 11, 2022
Estimated Study Completion Date : July 11, 2022


Group/Cohort Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. Disease Progression [ Time Frame: Within 12 months ]
    Defined as >10% relative decline in FVC and mortality at 12 months

  2. 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.


Secondary Outcome Measures :
  1. Serum and Plasma Biomarkers [ Time Frame: Baseline, 3 months, 12 months, 24 months ]
    SPD, MUC16, CA199, Nordic Neoepitopes


Other Outcome Measures:
  1. DLco [ Time Frame: Baseline, 3 months, 12 months, 24 months ]
    Diffusing Capacity of the Lung for Carbon Monoxide

  2. 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


Biospecimen Retention:   Samples With DNA
Blood (Serum, Plasma) Bronchoscopy Biopsy Samples (Optional)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants will be recruited from ILD and IPF clinics.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670576


Locations
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United Kingdom
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Prof Gisli Jenkins    0115 8231711    gisli.jenkins@nottingham.ac.uk   
Contact: Dr Gauri Saini    0115 9249924    gauri.saini@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
Nottingham University Hospitals NHS Trust

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03670576     History of Changes
Other Study ID Numbers: 18014
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibrosis
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases