Audio Technology To Detect Lung Cancer Earlier

NCT ID: NCT03566862

Last Updated: 2018-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-16

Study Completion Date

2018-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Neoplasms Cough

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lung cancer

Individuals with confirmed diagnosis of lung cancer including disease in the lungs and an active cough.

Leicester Cough Monitor (LCM)

Intervention Type 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.

COPD

Individuals with a confirmed diagnosis of COPD according to established criteria.

Leicester Cough Monitor (LCM)

Intervention Type 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.

Other (non-COPD) chronic lung disease

Individuals with a confirmed diagnosis of non-COPD chronic lung disease (e.g. pulmonary fibrosis, asthma).

Leicester Cough Monitor (LCM)

Intervention Type 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.

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).

Leicester Cough Monitor (LCM)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of the West of Scotland

OTHER

Sponsor Role collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role collaborator

Queen Mary University of London

OTHER

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kevin G Blyth, MD

Role: PRINCIPAL_INVESTIGATOR

NHSGG&C

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Queen Elizabeth University Hospital Glasgow

Glasgow, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Joanne McGarry

Role: CONTACT

01412321818

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kevin G Blyth, MD

Role: primary

G Blyth

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GN16ON719

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Early Detection of Lung Cancer
NCT03181256 ACTIVE_NOT_RECRUITING