EARTHSCAN Version 1.0
Research type
Research Study
Full title
Early diAgnosis Real-Time Healthcare System for CANcer Trial (EARTH SCAN)
IRAS ID
300047
Contact name
Manish Chand
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 17 days
Research summary
Abnormal growths in the colon and rectum are referred to as polyps. Colonoscopy is considered the ‘gold standard’ for detecting polyps, however, optical diagnosis of polyps is challenging with the naked eye and hence polyps of all sizes and subtypes are often sent to histopathology for diagnosis.
The EARTH SCAN is a single site study to evaluate whether the CADDIE system improves the endoscopists accuracy in the optical diagnosis of diminutive colorectal polyps (≤5mm).
The CADDIE system comprises a computer attached to the output of the endoscopy stack and a screen which shows the normal video output of the colon in real-time. Using artificial intelligence (AI)software, it highlights the characteristics of a polyp to help the endoscopist in their optical diagnosis of the polyp histology. Pressing on a foot pedal, connected to the computer, presents the information from the AI software to the user as an overlay on the endoscopy screen in text format.
The target population in the study is patients undergoing a scheduled colonoscopy as part of their routine clinical care. Consenting patients will be registered and randomised to the intervention (=routine colonoscopy with CADDIE characterisation AI system), or to the control group (=routine colonoscopy without CADDIE AI system). The endoscopist will be kept the same in both arms to minimise variation.
To answer the main research question, polyps identified and characterised by the endoscopist will be biopsied and sent for histopathology. We will compare the optical diagnosis of the polyps by the endoscopist against the histopathology when using the device, and when not using the device to assess whether the endoscopist diagnosis of the type of polyp present improves with using the CADDIE AI software.
We will recruit 420 patients into the study and the study will last up to one year. There are no study-related follow up visits.REC name
West of Scotland REC 4
REC reference
22/WS/0002
Date of REC Opinion
24 Feb 2022
REC opinion
Further Information Favourable Opinion