Clinical trial NCT04715347: Interstitial Lung Disease Within a Lung Cancer Screening
Official title: Interstitial Lung Disease Within a Lung Cancer Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Disease
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2021-01-20
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age 50-80
* Ever-smoker
* MDT diagnosis of ILD that has been detected through lung cancer screening or standard non-screening pathway
* Attended the regional ILD clinic

Exclusion Criteria:

* Unable to complete self-report questionnaire measures
* Unable to provide written informed consent

Primary outcomes:
measure: Determine the prevalence of ILD in participants of a community-based lung cancer screening programme.
timeFrame: 2 years 6 months
Secondary outcomes:
measure: Comparison of the symptom and psychological burden at diagnosis between patients diagnosed through a screening programme and patients diagnosed through routine care
timeFrame: 2 years
measure: Comparison of the quality of life between patients diagnosed through a screening programme and patients diagnosed through routine care using VAS questionnaires
timeFrame: through study completion, an average of 2 years
measure: Comparison of the quality of life between patients diagnosed through a screening programme and patients diagnosed through routine care using FSS questionnaire
timeFrame: through study completion, an average of 2 years
measure: Comparison of the quality of life between patients diagnosed through a screening programme and patients diagnosed through routine care using the LCQ questionnaire
timeFrame: through study completion, an average of 2 years
measure: Comparison of the quality of life between patients diagnosed through a screening programme and patients diagnosed through routine care using the UCSD-SBQ questionnaire
timeFrame: through study completion, an average of 2 years
measure: Comparison of the quality of life between patients diagnosed through a screening programme and patients diagnosed through routine care using SF-36 questionnaire
timeFrame: through study completion, an average of 2 years
measure: Comparison of the quality of life between patients diagnosed through a screening programme and patients diagnosed through routine care using the K-BILD questionnaire
timeFrame: through study completion, an average of 2 years
measure: Qualitative comparison of the radiological pattern being depicted by ATS/ERS ILD by the multidisciplinary team (MDT) agreed type between patients diagnosed through a screening programme and patients diagnosed through routine care
timeFrame: through study completion at Multidisiplinary Team (MDT) meetings, for an average of 2 years
measure: Lung function via full pulmonary function test in patients with diagnosed ILD between patients diagnosed through a screening programme and patients diagnosed through routine care
timeFrame: through study completion, an average of 2 years
measure: Lung function via shuttle walk tests (distance walked and oxygen saturation) in patients with diagnosed ILD between patients diagnosed through a screening programme and through routine care
timeFrame: through study completion, an average of 2 years
measure: Qualitative comparison of the treatment strategies between patients diagnosed with ILD through a screening programme and patients diagnosed through routine care, this is not a quantitative measure.
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS foundation trust
state: Greater Manchester
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: Jill Clayton-Smith, Professor
role: PRINCIPAL_INVESTIGATOR
References: