NCT04715347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

2.6 years

First QC Date

July 27, 2020

Last Update Submit

July 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Determine the prevalence of ILD in participants of a community-based lung cancer screening programme.

    This will be determined through analysing the prevalence of ILD in participants of the MCIP lung cancer screening pilot programme

    2 years 6 months

Secondary Outcomes (11)

  • Comparison of the symptom and psychological burden at diagnosis between patients diagnosed through a screening programme and patients diagnosed through routine care

    2 years

  • Comparison of the quality of life between patients diagnosed through a screening programme and patients diagnosed through routine care using VAS questionnaires

    through study completion, an average of 2 years

  • Comparison of the quality of life between patients diagnosed through a screening programme and patients diagnosed through routine care using FSS questionnaire

    through study completion, an average of 2 years

  • Comparison of the quality of life between patients diagnosed through a screening programme and patients diagnosed through routine care using the LCQ questionnaire

    through study completion, an average of 2 years

  • Comparison of the quality of life between patients diagnosed through a screening programme and patients diagnosed through routine care using the UCSD-SBQ questionnaire

    through study completion, an average of 2 years

  • +6 more secondary outcomes

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manchester University NHS foundation trust

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Jill Clayton-Smith, Professor

    Manchester University NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2020

First Posted

January 20, 2021

Study Start

November 11, 2017

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

July 14, 2023

Record last verified: 2023-07

Locations