Interstitial Lung Disease Within a Lung Cancer Screening
NCT ID: NCT04715347
Last Updated: 2023-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
36 participants
OBSERVATIONAL
2017-11-11
2020-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 provide written informed consent
50 Years
80 Years
ALL
No
Sponsors
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Manchester University NHS Foundation Trust
OTHER_GOV
Responsible Party
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Principal Investigators
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Jill Clayton-Smith, Professor
Role: PRINCIPAL_INVESTIGATOR
Manchester University NHS Foundation Trust
Locations
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Manchester University NHS foundation trust
Manchester, Greater Manchester, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2017TC011
Identifier Type: -
Identifier Source: org_study_id
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