Interstitial Lung Disease Within a Lung Cancer Screening
Condition: Interstitial Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Observational

Summary: 
      Interstitial lung disease is a devastating lung condition with terrible outcomes. Lung cancer
      is the world's leading cause of cancer related death. Unlike breast and bowel cancer, there
      is no lung cancer screening programme in the UK. However, there are a number of pilot lung
      cancer screening programmes taking place including one in Manchester. The CT scans used in
      lung cancer screening programmes pick up other lung conditions out with lung cancer,
      including interstitial lung disease. This provides a unique opportunity to diagnose
      interstitial lung disease at an early and non-symptomatic stage where treatment can be
      initiated early to halt progression of disease and development of symptoms. The investigators
      aim to determine how much (prevalence) interstitial lung disease can be picked up in a lung
      cancer screening programme and how these cases would compare to those diagnosed with
      interstitial lung disease through the 'standard' way in the clinics.

      The investigators hypothesis that the patients diagnosed through the screening programmes
      will have an earlier stage of disease with less symptoms. If this is to be the case, this
      would provide researchers with the opportunity to diagnose interstitial lung disease through
      lung cancer screening programmes and initiate treatment early.
    

Detailed description: 
      The Manchester Early Detection of Lung Disease Pilot (lung cancer screening programme) is
      already under way and has been for the past 12 months. A total of 1,384 individuals had a CT
      scan as part of this service. From these, several individuals (around 40) have been diagnosed
      with likely interstitial lung disease (ILD) and been referred to the regional ILD clinic at
      the University Hospital of South Manchester (UHSM; Wythenshawe). These patients are due to
      attend the clinic soon.

      Individuals attending the regional ILD clinic as a 'new referral' will be invited to
      participate. Inclusion and exclusion criteria will be evaluated, and suitable participants
      will be provided with a patient information sheet (PIS) on the same day prior to written
      consent being obtained for enrolment into the study. Individuals will be given as much time
      as needed to read the PIS and ask relevant questions. We will recruit patients from two
      groups:

        -  Group 1: ILD diagnosed through the Manchester Early Detection of Lung Disease Pilot
           (lung cancer screening programme) and

        -  Group 2: age and sex matched individuals with ILD diagnosed through standard
           non-screening pathway

      Participants will be asked to fill out a number of health-related questionnaires in addition
      to the standard care they will receive as part of their clinic visit. No extra tests will be
      performed as a result of this study, the only additional information required is related to
      the questionnaires. These questionnaires will focus on quality of life and symptom burden and
      will on average take 10-15 minutes to complete. The information gathered from their clinic
      visit (including any tests performed) will also be collected and used for research purposes.
      Once complete, the results between group 1 and group 2 will be compared.

      Overall there will be three time points in the study for each participant to fill out
      questionnaires. This will be at the baseline visit (as above) and also at 6 months and 12
      months. The 6 month and 12 month questionnaires will be completed by participants, with as
      required help from the research team, at a follow-up clinic visit if one is set up (ILD
      clinic patients are often seen back in clinic at these time points). If not clinic
      appointment is set up at these time points, the questionnaires will be posted to the
      participants for self-completion at home with help offered over the phone as required.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals attending the regional ILD clinic as a 'new referral' who have been referred
        from a lung cancer screening programme or through a standard non-screening pathway will be
        invited to participate.