Lung NeoplasmsNCT03566862
Audio Technology To Detect Lung Cancer Earlier
An observational study of Lung Neoplasms and Cough, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
A cross-sectional study of prospectively collected cough audio recordings using spectral analysis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lung Neoplasms, Cough
- What is being tested?
- Leicester Cough Monitor (LCM)
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 May 2017to 30 Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants for all 4 cohorts will be identified by the CI and associated research team by screening patients who attend respiratory clinics at QEUH with suspected lung cancer (for the "Normal Smokers" and Lung Cancer cohorts) and other established respiratory diseases (for the COPD and Other (non-COPD) chronic lung disease cohorts). Individuals will be recruited by the QEUH research nurse or CI when they attend the relevant outpatient clinics.
Who may be able to join
- Aged 50 years and above and who are either:
- "Normal Smokers" - individuals who have presented with cough but who appear to have 'healthy' lungs (i.e. COPD, other chronic lung disease and lung cancer have been excluded after clinical assessment);
- "COPD" - individuals with a confirmed diagnosis of COPD according to established criteria;
- "Other (non-COPD) chronic lung disease" - individuals with a confirmed diagnosis of non-COPD chronic lung disease (e.g. pulmonary fibrosis, asthma);
- "Lung cancer" - individuals with confirmed diagnosis of lung cancer including disease in the lungs and an active cough
Who cannot join
- Participants with an active or recent lung infection, as defined by either the production of purulent sputum associated with systemic symptoms or fever, and/or the receipt of antibiotics for lung infection or acute exacerbation over the 2 weeks preceding the date of consent
- Participants who are unable to provide informed consent
- Participants who are receiving/have previously received radiotherapy to the lungs
- Participants who are currently receiving chemotherapy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth University Hospital Glasgow
Glasgow, G51 4TF
Kevin G Blyth, MD, kevin.blyth@ggc.scot.nhs.uk
G Blyth
About this study
A cross-sectional study of prospectively collected cough audio recordings using spectral analysis.
Read the detailed description
In the UK lung cancer is the leading cause of cancer death, also, UK survival rates are poorer compared to other European countries. Lung cancer is plagued by late presentation; 70% present with advanced incurable disease and a third die within 90 days of diagnosis. As such, there is a clear and urgent need to achieve earlier diagnosis of lung cancer. Symptomatic presentation is the most common route to lung cancer diagnosis and symptoms may be present for many months before diagnosis, even in early stage disease. The most common (68%) presenting symptom is cough. Unfortunately cough is also common with other illnesses. Furthermore, a high proportion of those at high-risk of lung cancer have pre-existing cough or respiratory disease (e.g. ex- or current- smokers, patients with chronic obstructive pulmonary disease (COPD)). Cough sounds are known to vary according to underlying lung pathology and could therefore have diagnostic value. Potentially, there may be unique cough and/or respiratory sounds or patterns associated with lung cancer that are not detectable by the human audio spectrum. Identification of a tool that accurately discriminates lung cancer cough could be pivotal.
This is a prospective cross-sectional study that will involve subjective analysis of spectrograms of cough recorded from individuals with "normal" lungs, individuals at high-risk for lung cancer (COPD and other chronic lung diseases) and individuals with lung cancer. 24 hour ambulatory audio recordings will be prospectively collected from patients attending respiratory medicine clinics at Queen Elizabeth University Hospital (QEUH), Glasgow. Participants will be given a free-field lapel microphone and mp3 recorder for 24h. The Leicester Cough Monitor (LCM) will be used to extract the cough sounds from the 24h recordings. The LCM is an automated cough detection system that was developed by Dr Surinder Birring (Kings College Hospital). It uses an algorithm to automatically identify cough sounds from audio recordings, which is then able to provide data on cough frequency. As part of this process, the LCM splices out 1 second sound clips for all parts of the audio recordings that are identified as being (i) a cough sound or (ii) a non-cough sound.
- Conditions
- Lung Neoplasms, Cough
- Being tested
- Leicester Cough Monitor (LCM)
- Medical subject headings
- Lung Neoplasms, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leicester Cough Monitor (LCM)Diagnostic test
The Leicester Monitoring Cough (LCM) kit includes a digital flash voice recorder (Sony ICD-PX333), aA clip-on lapel microphone (Philips LFH9173) and a small carry/travel waist bag.
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer | Individuals with confirmed diagnosis of lung cancer including disease in the lungs and an active cough. Receives: Diagnostic Test: Leicester Cough Monitor (LCM) | |
| COPD | Individuals with a confirmed diagnosis of COPD according to established criteria. Receives: Diagnostic Test: Leicester Cough Monitor (LCM) | |
| Other (non-COPD) chronic lung disease | Individuals with a confirmed diagnosis of non-COPD chronic lung disease (e.g. pulmonary fibrosis, asthma). Receives: Diagnostic Test: Leicester Cough Monitor (LCM) | |
| Normal smokers | Individuals who have presented with cough but who appear to have 'healthy' lungs (i.e. COPD, other chronic lung disease and lung cancer have been excluded after clinical assessment). Receives: Diagnostic Test: Leicester Cough Monitor (LCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectral centroid (Hz) measurement
Spectral centroid (Hz) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples
Measured: 12 months
Secondary outcomes (11)
Spectral bandwith (Hz) measurement
Spectral bandwith (Hz) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples
Measured: 12 months
Spectral crest factor (Hz) measurement
Spectral crest factor (Hz) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples
Measured: 12 months
Spectral flatness (adimensional) measurement
Spectral flatness (adimensional) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples
Measured: 12 months
Spectral flux (Watts²) measurement
Spectral flux (Watts²) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples
Measured: 12 months
Spectral roll-off (Hz) measurement
Spectral roll-off (Hz) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples
Measured: 12 months
Ratio f50 vs f90 (adimensional) measurement
Ratio f50 vs f90 (adimensional) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples
Measured: 12 months
Spectral peak entropy (adimensional measurement)
Spectral peak entropy (adimensional measurement) of cough sounds to ascertain any similarities or differences in spectral characteristics between samples
Measured: 12 months
Spectral Renyi entropy (adimensional) measurement
Spectral Renyi entropy (adimensional) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples
Measured: 12 months
Spectral kurtosis (adimensional) measurement
Spectral kurtosis (adimensional) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples
Measured: 12 months
Spectral skewness (adimensional) measurement
Spectral skewness (adimensional) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples
Measured: 12 months
Spectral entropy (adimensional) measurement
Spectral entropy (adimensional) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start16 May 2017
- Primary completion30 Nov 2018 (estimated)
- Study completion30 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of the West of Scotland, King's College Hospital NHS Trust, Queen Mary University of London
- Responsible party
- Sponsor
- Investigators
- Kevin G Blyth, MD, Principal investigator, NHSGG&C
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566862
- Sponsor's protocol ID
- GN16ON719
- Status last verified
- Jun 2018
- First submitted
- 15 May 2018
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audio Technology To Detect Lung Cancer Earlier
- ClinicalTrials.gov ID
- NCT03566862
- Acronym / sponsor ID
- GN16ON719
- Conditions
- Lung Neoplasms, Cough
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of the West of Scotland, King's College Hospital NHS Trust, Queen Mary University of London
- Study start
- 16 May 2017 (actual)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 25 Jun 2018 (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.
A cross-sectional study of prospectively collected cough audio recordings using spectral analysis.
Detailed description
In the UK lung cancer is the leading cause of cancer death, also, UK survival rates are poorer compared to other European countries. Lung cancer is plagued by late presentation; 70% present with advanced incurable disease and a third die within 90 days of diagnosis. As such, there is a clear and urgent need to achieve earlier diagnosis of lung cancer. Symptomatic presentation is the most common route to lung cancer diagnosis and symptoms may be present for many months before diagnosis, even in early stage disease. The most common (68%) presenting symptom is cough. Unfortunately cough is also common with other illnesses. Furthermore, a high proportion of those at high-risk of lung cancer have pre-existing cough or respiratory disease (e.g. ex- or current- smokers, patients with chronic obstructive pulmonary disease (COPD)). Cough sounds are known to vary according to underlying lung pathology and could therefore have diagnostic value. Potentially, there may be unique cough and/or respiratory sounds or patterns associated with lung cancer that are not detectable by the human audio spectrum. Identification of a tool that accurately discriminates lung cancer cough could be pivotal.
This is a prospective cross-sectional study that will involve subjective analysis of spectrograms of cough recorded from individuals with "normal" lungs, individuals at high-risk for lung cancer (COPD and other chronic lung diseases) and individuals with lung cancer. 24 hour ambulatory audio recordings will be prospectively collected from patients attending respiratory medicine clinics at Queen Elizabeth University Hospital (QEUH), Glasgow. Participants will be given a free-field lapel microphone and mp3 recorder for 24h. The Leicester Cough Monitor (LCM) will be used to extract the cough sounds from the 24h recordings. The LCM is an automated cough detection system that was developed by Dr Surinder Birring (Kings College Hospital). It uses an algorithm to automatically identify cough sounds from audio recordings, which is then able to provide data on cough frequency. As part of this process, the LCM splices out 1 second sound clips for all parts of the audio recordings that are identified as being (i) a cough sound or (ii) a non-cough sound.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lung cancer | – | Diagnostic Test: Leicester Cough Monitor (LCM)Individuals with confirmed diagnosis of lung cancer including disease in the lungs and an active cough. |
| COPD | – | Diagnostic Test: Leicester Cough Monitor (LCM)Individuals with a confirmed diagnosis of COPD according to established criteria. |
| Other (non-COPD) chronic lung disease | – | Diagnostic Test: Leicester Cough Monitor (LCM)Individuals with a confirmed diagnosis of non-COPD chronic lung disease (e.g. pulmonary fibrosis, asthma). |
| Normal smokers | – | Diagnostic Test: Leicester Cough Monitor (LCM)Individuals who have presented with cough but who appear to have 'healthy' lungs (i.e. COPD, other chronic lung disease and lung cancer have been excluded after clinical assessment). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants for all 4 cohorts will be identified by the CI and associated research team by screening patients who attend respiratory clinics at QEUH with suspected lung cancer (for the "Normal Smokers" and Lung Cancer cohorts) and other established respiratory diseases (for the COPD and Other (non-COPD) chronic lung disease cohorts). Individuals will be recruited by the QEUH research nurse or CI when they attend the relevant outpatient clinics.
Key inclusion criteria (5 listed)
- Aged 50 years and above and who are either:
- "Normal Smokers" - individuals who have presented with cough but who appear to have 'healthy' lungs (i.e. COPD, other chronic lung disease and lung cancer have been excluded after clinical assessment);
- "COPD" - individuals with a confirmed diagnosis of COPD according to established criteria;
- "Other (non-COPD) chronic lung disease" - individuals with a confirmed diagnosis of non-COPD chronic lung disease (e.g. pulmonary fibrosis, asthma);
- "Lung cancer" - individuals with confirmed diagnosis of lung cancer including disease in the lungs and an active cough
Key exclusion criteria (4 listed)
- Participants with an active or recent lung infection, as defined by either the production of purulent sputum associated with systemic symptoms or fever, and/or the receipt of antibiotics for lung infection or acute exacerbation over the 2 weeks preceding the date of consent
- Participants who are unable to provide informed consent
- Participants who are receiving/have previously received radiotherapy to the lungs
- Participants who are currently receiving chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leicester Cough Monitor (LCM)The Leicester Monitoring Cough (LCM) kit includes a digital flash voice recorder (Sony ICD-PX333), aA clip-on lapel microphone (Philips LFH9173) and a small carry/travel waist bag. | Diagnostic test | COPD, Lung cancer, Normal smokers, Other (non-COPD) chronic lung disease |
Primary outcome
Spectral centroid (Hz) measurement
Time frame: 12 months
Spectral centroid (Hz) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples
11 secondary outcomes
Spectral bandwith (Hz) measurement
Time frame: 12 months
Spectral crest factor (Hz) measurement
Time frame: 12 months
Spectral flatness (adimensional) measurement
Time frame: 12 months
Spectral flux (Watts²) measurement
Time frame: 12 months
Spectral roll-off (Hz) measurement
Time frame: 12 months
Ratio f50 vs f90 (adimensional) measurement
Time frame: 12 months
Spectral peak entropy (adimensional measurement)
Time frame: 12 months
Spectral Renyi entropy (adimensional) measurement
Time frame: 12 months
Spectral kurtosis (adimensional) measurement
Time frame: 12 months
Spectral skewness (adimensional) measurement
Time frame: 12 months
Spectral entropy (adimensional) measurement
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Kevin G Blyth, MD principal investigator
NHSGG&C
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 Lung Neoplasms and Cough, run by NHS Greater Glasgow and Clyde 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanne McGarry (01412321818, Joanne.McGarry@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spectral centroid (Hz) measurement (time frame: 12 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 25 Jun 2018.