Colonic Neoplasms Clinical Trial
Official title:
Real-World Validation of an Artificial Intelligence Characterization Support (CADx) System for Prediction of Polyp Histology in Colonoscopy: A Prospective Multicentre Study
Verified date | February 2023 |
Source | Changi General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Colorectal cancer (CRC) is a leading cause of cancer-related morbidity and mortality worldwide, with rates of CRC predicted to increase. Colonoscopy is currently the gold standard of screening for CRC. Artificial intelligence (AI) is seen as a solution to bridge this gap in adenoma detection, which is a quality indicator in colonoscopy. AI systems utilize deep neural networks to enable computer-aided detection (CADe) and computer-aided classification (CADx). CADe is concerned with the detection of polyps during colonoscopy, which in turn is postulated to help decrease the adenoma miss-rate. In contrast, CADx deals with the interpretation of polyp appearance during colonoscopy to determine the predicted histology. Prediction of polyp histology is crucial in helping Clinicians decide on a "resect and discard" or "diagnose and leave strategy". It is also useful for the Clinician to be aware of the predicted histology of a colorectal polyp in determining the appropriate method of resection in terms of safety and efficacy. While CADe has been studied extensively in randomized controlled trials, there is a lack of prospective data validating the use of CADx in a clinical setting to predict polyp histology. The investigators plan to conduct a prospective, multi-centre clinical trial to validate the accuracy of CADx support for prediction of polyp histology in real-time colonoscopy.
Status | Completed |
Enrollment | 450 |
Est. completion date | October 1, 2022 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: 1. Patients who have an indication for colonoscopy and who have at least one polyp detected during colonoscopy 2. 40 years of age and above 3. Consent obtained for the study Exclusion Criteria: 1. Less than 39 years of age 2. Declined participation in study 3. Patients with no polyps detected during colonoscopy 4. Patients with inflammatory bowel disease 5. Patients with known unresected colorectal cancer |
Country | Name | City | State |
---|---|---|---|
Singapore | Changi General Hospital, National University Hospital, Singapore General Hospital and Tan Tock Seng Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Changi General Hospital | National University Hospital, Singapore, Singapore General Hospital, Tan Tock Seng Hospital |
Singapore,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the diagnostic performance of the CADx support tool compared to optical prediction of polyp histology by the Clinician in real-time colonoscopy in a clinical setting | Polyp histology used as gold standard | 1 year | |
Secondary | To determine the diagnostic performance of CADx versus optical prediction of polyp histology by endoscopist in the subgroup analysis | Subgroups include bowel preparation, size of polyp and location | 1 year |
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