Interstitial Lung Disease Within a Lung Cancer Screening

NCT ID: NCT04715347

Last Updated: 2023-07-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-11

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Interstitial Lung Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2017TC011

Identifier Type: -

Identifier Source: org_study_id

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