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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 : July 8, 2019
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 Other: Home Hand Held Spirometry

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 : November 11, 2018
Estimated Primary Completion Date : November 11, 2022
Estimated Study Completion Date : November 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.

Other: Home Hand Held Spirometry
Patients possessing a smart phone can download an app and are given a small hand held device to record their own spirometry at home. This is for the first three months on study. this is optional.

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.

Other: Home Hand Held Spirometry
Patients possessing a smart phone can download an app and are given a small hand held device to record their own spirometry at home. This is for the first three months on study. this is optional.




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

  3. Domicillary Spirometry [ Time Frame: Daily for the first 3 months of study ]
    Predicting disease progression and survival


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

Inclusion Criteria

  • Male or female aged ≥ 18 years old
  • Able and willing to give written informed consent
  • Recently diagnosed [defined as diagnostic CT scan or surgical lung biopsy (if applicable) >1st May 2017]
  • An MDT diagnosis of fibrotic interstitial lung disease (reticulation, traction +/- honeycombing)

Sub Groups

  • Rheumatoid arthritis (rheumatologist diagnosed with anti-CCP antibodies and/or Rheumatoid Factor positive)
  • Asbestosis (appropriate occupational history and radiological evidence of asbestos exposure)
  • Chronic HP in accordance with consensus criteria (appropriate exposure history, radiological features +/- avian and fungal precipitins)
  • Unclassifiable fibrotic lung disease (fibrotic lung disease otherwise unclassifiable despite extensive clinical and radiological examination)
  • IPF in accordance with consensus criteria (ATS/ERS/JRS/ALAT guidelines) as controls

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 cannot partake in the domiciliary spirometry.

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


Contacts
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Contact: Prof Gisli Jenkins 0115 8231711 gisli.jenkins@nottingham.ac.uk
Contact: Lucy Howard 01158231326 lucy.howard@nottingham.ac.uk

Locations
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United Kingdom
Queens Hospital Burton Recruiting
Burton on Trent, Derbyshire, United Kingdom, DE15 0RB
Contact: Dr Uttam Nanda         
Kings Mill Hospital Recruiting
Mansfield, Nottingham, United Kingdom, NG17 4JL
Contact: Dr Khaled Amsha         
Southmead Hospital North Bristol Recruiting
Bristol, United Kingdom, BS10 5NB
Contact: Dr Huzaifa Adamali         
University Hospitals Coventry and Warwickshire Recruiting
Coventry, United Kingdom, CV2 2DX
Contact: Dr Dhananjay Desai         
Royal Derby Hospital Recruiting
Derby, United Kingdom, DE22 3NE
Contact: Dr Srividya Narayan         
Royal Devon and Exeter Hospital Recruiting
Exeter, United Kingdom, EX2 5DW
Contact: Sarah Lines         
Medway Maritime Hospital Recruiting
Gillingham, United Kingdom, ME7 5NY
Contact: Dr Lisa Vincent-Smith         
North Manchester General Hospital Recruiting
Manchester, United Kingdom, M8 5RB
Contact: Dr Zoe Borrill         
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Prof Gisli Jenkins    0115 8231711    gisli.jenkins@nottingham.ac.uk   
Contact: Lucy Howard    0115 8231326    lucy.howard@nottingham.ac.uk   
South Tyneside District Hospital Recruiting
South Shields, United Kingdom, NE34 0PL
Contact: Dr Liz Fuller         
University Hospital of North Tees Recruiting
Stockton-on-Tees, United Kingdom, TS19 8PE
Contact: Dr Graham Miller         
Royal Albert and Edward Infirmary Recruiting
Wigan, United Kingdom, WN1 2NN
Contact: Dr Abdul Ashish         
New Cross Hospital Recruiting
Wolverhampton, United Kingdom, WV10 0QP
Contact: Dr Ahmed Fahim         
Worcestershire Royal Hospital Recruiting
Worcester, United Kingdom, WR5 1DD
Contact: Prof Stephen O'Hickey         
Sponsors and Collaborators
University of Nottingham
Nottingham University Hospitals NHS Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: July 8, 2019
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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Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Fibrosis
Pathologic Processes
Respiratory Tract Diseases