Interstitial Lung DiseaseILDNCT04715347
Interstitial Lung Disease Within a Lung Cancer Screening
An observational study of Interstitial Lung Disease, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Interstitial Lung Disease
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Nov 2017to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Unable to complete self-report questionnaire measures
- Unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS foundation trust
Manchester, Greater Manchester, M13 9WL
About this study
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.
Read the 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.
- Conditions
- Interstitial Lung Disease
- Medical subject headings
- Lung Diseases, Interstitial
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
This will be determined through standardised clinical history pro forma's
Measured: 2 years
Comparison of the quality of life between patients diagnosed through a screening programme and patients diagnosed through routine care using VAS questionnaires
Using VAS questionnaires with a scale of the worst to none
Measured: 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
Using FSS questionnaire with a scale of 1-7. With 1 being strong disagreement and 7 being strong agreement
Measured: 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
LCQ questionnaire with a scale of 1-7 with All the time to Never varying on the scale.
Measured: 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
UCSD-SBQ questionnaire, which has a scale of 0-5, with 0 being none and 5 maximum
Measured: 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 SF-36 questionnaire
Using SF-36 questionnaire.The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability
Measured: 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 K-BILD questionnaire
K-BILD questionnaire with a scale of 1-7 , with 1 being all the time and 7 being never/ none of the time
Measured: through study completion, an average of 2 years
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
Any Interstitial lung abnormalities (ILAs) detected on screening LDCT scans were highlighted in the CT report and referred to the regional ILD MDT for review and discussion. The radiological pattern will be established from the multidisciplinary team (MDT) pro forma's, this will be a descriptive analysis.
The MDT consists of three ILD respiratory physicians, a thoracic radiologist with an interest in ILD, two specialist ILD nurses and an MDT co-ordinator. Once discussed at the MDT, those deemed to have changes suggestive of significant ILD have been referred to the regional ILD service for assessment in the clinic.
Measured: through study completion at Multidisiplinary Team (MDT) meetings, for an average of 2 years
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
Comparison of lung function averages will be determined, a full pulmonary function test (Forced vital capacity (FVC) and transfer factor (DLCO) at diagnosis). This outcome will be comparing patients who have been diagnosed through the standard non-screening pathway and the screening programme.
Measured: through study completion, an average of 2 years
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
Comparison of lung function averages will be determined using shuttle walk tests, distance walked and oxygen saturation (pre and immediately post test). This outcome will be comparing patients who have been diagnosed through the standard non-screening pathway and the screening programme.
Measured: through study completion, an average of 2 years
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.
This will be assessed through the initial treatment patients received, this will be a descriptive analysis or qualitative nature .
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start11 Nov 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jill Clayton-Smith, Professor, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715347
- Sponsor's protocol ID
- 2017TC011
- Acronym
- ILD
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2020
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Lung Disease Within a Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT04715347
- Acronym / sponsor ID
- ILD / 2017TC011
- Conditions
- Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 11 Nov 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to complete self-report questionnaire measures
- Unable to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the prevalence of ILD in participants of a community-based lung cancer screening programme.
Time frame: 2 years 6 months
This will be determined through analysing the prevalence of ILD in participants of the MCIP lung cancer screening pilot programme
11 secondary outcomes
Comparison of the symptom and psychological burden at diagnosis between patients diagnosed through a screening programme and patients diagnosed through routine care
Time frame: 2 years
Comparison of the quality of life between patients diagnosed through a screening programme and patients diagnosed through routine care using VAS questionnaires
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 SF-36 questionnaire
Time frame: 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 K-BILD questionnaire
Time frame: through study completion, an average of 2 years
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
Time frame: through study completion at Multidisiplinary Team (MDT) meetings, for an average of 2 years
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
Time frame: through study completion, an average of 2 years
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
Time frame: through study completion, an average of 2 years
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.
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Clayton-Smith, Professor principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the prevalence of ILD in participants of a community-based lung cancer screening programme. (time frame: 2 years 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.