Early DiAgnosis Real-Time Healthcare System for CANcer Trial

Launched by UNIVERSITY COLLEGE, LONDON · Sep 21, 2021

Keywords

ClinConnect Summary

The Early diAgnosis Real-Time Healthcare System for CANcer Trial is studying whether a new artificial intelligence (AI) system, called the CADDIE device, can help doctors more accurately identify small growths in the colon, known as polyps, during a procedure called a colonoscopy. In this trial, participants will be randomly assigned to one of two groups: one group will have their colonoscopy with the assistance of the CADDIE device, while the other group will have the standard procedure without the device.

To be eligible for the trial, participants must be at least 18 years old and scheduled for a colonoscopy, which could be for screening, monitoring, or symptoms. However, people with certain conditions, such as active colorectal cancer or inflammatory bowel disease, cannot participate. If you join the trial, you can expect to have the colonoscopy as usual, whether with or without the CADDIE device, and your participation will help researchers learn more about improving the accuracy of polyp diagnosis. This trial is currently recruiting participants of all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants scheduled to undergo a screening, surveillance or symptomatic colonoscopy with an endoscopist participating in the study phase of the trial.
• • Male and female participants aged 18 years or older at the time of informed consent.
• • Participants able to comprehend, sign and date the written informed consent document to participate in the study.
• Exclusion Criteria:
• • Emergency and/or inpatient colonoscopies
• • Participants with inflammatory bowel disease (IBD)
• • Participants with current Colorectal Cancer (CRC)
• * Participants with a contraindication for biopsy or polypectomy. These include:
• • Participants who have not withheld medications pre-disposing to bleeding at time of colonoscopy as per local site /national guidelines.
• • Participants with a history of haemostasis disorders (haemostasis disorders will include but will not be limited to: participants with haemophilia or other congenitally acquired clotting factor deficiencies, participants with cirrhosis with coagulopathy, participants known to have thrombocytopenia (\<80,000 platelet/ul) and individuals with Von Willebrand's disease or other known platelet malfunction disorders)
• • Participant is enrolled in another research study with an investigational medicinal product (IMP) or non-IMP that pre-disposes them to bleeding