RecruitingNCT06447012

Artificial Intelligence Development for Colorectal Polyp Diagnosis

Development of a Novel Real Time Computer Assisted Colonoscopy Diagnostic Tool for Colorectal Polyps: Lesion Diagnosis and Personalised Patient Management


Sponsor

King's College Hospital NHS Trust

Enrollment

4,000 participants

Start Date

May 4, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Accurate classification of growths in the large bowel (polyps) identified during colonoscopy is imperative to inform the risk of colorectal cancer. Reliable identification of the cancer risk of individual polyps helps determine the best treatment option for the detected polyp and determine the appropriate interval requirements for future colonoscopy to check the site of removal and for further polyps elsewhere in the bowel. Current advanced endoscopic imaging techniques require specialist skills and expertise with an associated long learning curve and increased procedure time. It is for these reasons that despite being introduced in clinical practice, uptake of such techniques is limited and current methods of polyp risk stratification during colonoscopy without Artificial intelligence (AI) is suboptimal. Approximately 25% of bowel polyps that are removed by major surgery are analysed and later proved to be non-cancerous polyps that could have been removed via endoscopy thus avoiding anatomy altering surgery and the associated risks. With accurate polyp diagnosis and risk stratification in real time with AI, such polyps could have been removed non-surgically (endoscopically). Current Computer Assisted Diagnosis (CADx, a form of AI) platforms only differentiate between cancerous and non cancerous polyps which is of limited value in providing a personalised patient risk for colorectal cancer. The development of a multi-class algorithm is of greater complexity than a binary classification and requires larger training and validation datasets. A robust CADx algorithm should also involve global trainable data to minimise the introduction of bias. It is for these reasons that this is a planned international multicentre study. The Investigators aim to develop a novel AI five class pathology prediction risk prediction tool that provides reliable information to identify cancer risk independent of the endoscopists skill. These 5 categories are chosen because treatment options differ according to the polyp type and future check colonoscopy guidelines require these categories


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study develops and validates an artificial intelligence (AI) tool that can analyze images taken during a colonoscopy and accurately classify colon polyps — small growths in the bowel that can sometimes become cancerous — to help doctors make better real-time decisions. **You may be eligible if...** - You are over 18 years old - You are scheduled for a colonoscopy either as a screening procedure or because of symptoms **You may NOT be eligible if...** - You are unable to give informed consent - You have colitis-associated dysplasia (abnormal cells linked to inflammatory bowel disease) - You have polyps located at a surgical reconnection site (anastomosis) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTColonoscopy

No intervention required from this study, however images will be obtained from patient presenting for colonoscopy


Locations(1)

King's College Hospital NHS Foundation Trust

London, United Kingdom

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NCT06447012


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