EARL version 1.0
Research type
Research Study
Full title
Electrocautery Ablation for the Prevention of Lung Cancer
IRAS ID
263980
Contact name
Sam Janes
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
The EARL study aims to prevent squamous cell lung carcinoma, which accounts for a third of all UK lung cancers. The cells that line our airways undergo genetic and structural changes when exposed to harmful chemicals in cigarette smoke, until they can spread outside the airway wall - the stage we term cancer. The steps that occur before cancer are termed ‘pre-invasive’. Pre-invasive lesions (a lesion is a group of these abnormal cells) are categorised into high-grade lesions (HGLs) and low-grade (LGLs), depending on their risk of progression to cancer.
In the UK, there is no standard practice for managing these lesions. Some patients undergo monitoring of their lesions using autofluorescence bronchoscopy (AFB) whereby a blue light is shone from a bronchoscope that illuminates these lesions - termed ‘AFB surveillance’ - whereas other patients may not be monitored at all. Patients do not typically receive treatment unless the lesion(s) develop into cancer.
When treating HGLs, some centres will surgically remove them, but this has marked limitations: their central location means large sections of lung need removal and patients frequently have other health problems which preclude safe anaesthesia. Other centres adopt a less invasive approach, using treatments delivered by bronchoscopy such as electrocautery (EC). This utilises an electric current that burns away the abnormal cells. Small studies have suggested EC may be effective in reducing the risk of airway HGLs becoming cancer but this has never been proven in a randomised controlled trial.
This study will follow-up patients for 3 years from four hospital sites and will compare EC treatment and AFB surveillance with AFB surveillance alone. The study will be randomised meaning neither doctors nor patients can choose which treatment they receive. Study recruitment will last 36 months and study duration will be 72 months.
REC name
London - Bromley Research Ethics Committee
REC reference
19/LO/1299
Date of REC Opinion
14 Oct 2019
REC opinion
Further Information Favourable Opinion