Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04715347
Status:
COMPLETED
Last Update Posted:
2023-07-14
First Post:
2020-07-27
Brief Title:
Interstitial Lung Disease Within a Lung Cancer Screening
Sponsor:
Manchester University NHS Foundation Trust
Organization:
Manchester University NHS Foundation Trust
Study Overview
Official Title:
Interstitial Lung Disease Within a Lung Cancer Screening
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ILD
Brief Summary:
Interstitial lung disease is a devastating lung condition with terrible outcomes Lung cancer is the worlds 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
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 1384 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None