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It's Not JUST Idiopathic Pulmonary Fibrosis Study (INJUSTIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03670576
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : July 2, 2021
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 will download an app and are given a small hand held device to record their own spirometry at home. This is blinded for the first three months of the study and then requested a week before and a week after the three follow up points (3m, 12m, 24m)

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 will download an app and are given a small hand held device to record their own spirometry at home. This is blinded for the first three months of the study and then requested a week before and a week after the three follow up points (3m, 12m, 24m)




Primary Outcome Measures :
  1. 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.

  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 then at 2 week periods around time of planned follow up ]
    Change in home handheld spirometry values from baseline to 12 weeks


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 or have a valid email address (necessary for the home FVC readings)

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
Show Show 24 study locations
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    
Other Study ID Numbers: 18014
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: July 2021

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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
Lung Diseases, Interstitial
Fibrosis
Pathologic Processes
Respiratory Tract Diseases