Audio Technology To Detect Lung Cancer Earlier

A cross-sectional study of prospectively collected cough audio recordings using spectral analysis.

Study Overview

• Status: Unknown
• Conditions: Lung Neoplasms; Cough
• Intervention / Treatment: Diagnostic test: Leicester Cough Monitor (LCM)

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Joanne McGarry; Phone Number: 01412321818; Email: Joanne.McGarry@ggc.scot.nhs.uk

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G51 4TF
    • Recruiting
    • Queen Elizabeth University Hospital Glasgow
    • Contact: Kevin G Blyth, MD; Email: kevin.blyth@ggc.scot.nhs.uk
    • Contact: G Blyth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung cancer; Individuals with confirmed diagnosis of lung cancer including disease in the lungs and an active cough.	Diagnostic test: 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.
COPD; Individuals with a confirmed diagnosis of COPD according to established criteria.	Diagnostic test: 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.
Other (non-COPD) chronic lung disease; Individuals with a confirmed diagnosis of non-COPD chronic lung disease (e.g. pulmonary fibrosis, asthma).	Diagnostic test: 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.
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).	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spectral centroid (Hz) measurement	Spectral centroid (Hz) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spectral bandwith (Hz) measurement	Spectral bandwith (Hz) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples	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	12 months
Spectral flatness (adimensional) measurement	Spectral flatness (adimensional) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples	12 months
Spectral flux (Watts²) measurement	Spectral flux (Watts²) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples	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	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	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	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	12 months
Spectral kurtosis (adimensional) measurement	Spectral kurtosis (adimensional) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples	12 months
Spectral skewness (adimensional) measurement	Spectral skewness (adimensional) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples	12 months
Spectral entropy (adimensional) measurement	Spectral entropy (adimensional) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples	12 months

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: King's College Hospital NHS Trust; Queen Mary University of London; University of the West of Scotland
• Investigators: Principal Investigator: Kevin G Blyth, MD, NHSGG&C

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2017
• Primary Completion (Anticipated): November 30, 2018
• Study Completion (Anticipated): November 30, 2018

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: June 21, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 21, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: GN16ON719

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No