Improving Optical Diagnosis of Colorectal Polyps Using CADx and BASIC.

Study Overview
=================
Brief Summary
-----------------
Primary, this study aims to develop and validate a computer-aided diagnosis (CADx) system for the characterization of colorectal polyps. Second, this study evaluates the effect of using a clinical classification model Blue Light Imaging Adenoma Serrated International (BASIC) on the diagnostic accuracy of the optical diagnosis of colorectal polyps compared to intuitive optical diagnosis for both expert endoscopists and novices.

Detailed Description
-----------------
Optical diagnosis of colorectal polyps, the in-vivo characterization of the histology by endoscopists, is of increasing interest for clinical endoscopy practice. Recent studies have shown that thresholds for optical diagnosis are met in highly selected groups of expert endoscopists, but the same is not true in community endoscopy practices. In order to improve optical diagnosis, imaging enhancement techniques and the use of artificial intelligence are proposed. This observational study developes a computer-aided diagnosis (CADx) system to differentiate between benign and (pre-)malignant CRPs, using state-of-the-art machine learning methods and deep learning architectures. For the development, HDWL and BLI images are used. The CADx is trained using histology as gold standard. The CADx is externally validated using on a set of 60 colorectal polyps. This study will evaluate if the optical diagnosis of colorectal polyps can be improved with the aid of CADx. In addition, both expert endoscopists and novices optically diagnose the colorectal polyps. In the first, pre-training phase, endoscopists optically diagnose colorectal polyps based on intuition. Afterwards, in the post-training phase, the same set of colorectal polyps is optically diagnosed based on a clinical classification system; BLI Adenoma Serrated International Classification (BASIC). This study will evaluate if the optical diagnosis of colorectal polyps can be improved with the aid of BASIC in both expert and non-expert hands.

Official Title
-----------------
Improving Optical Diagnosis of Colorectal Polyps Using Computer-aided Diagnosis (CADx) and the BLI Adenoma Serrated International Classification (BASIC).

Conditions
-----------------
Colorectal Cancer, Colorectal Polyp

Intervention / Treatment
-----------------
* Other: Computer-aided diagnosis (CADx)
* Other: BLI Adenoma Serrated International Classification (BASIC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with at least one colorectal polyp found and resected during colonoscopy in regular care; Availability of at least one high definition white light image and one Blue Light Imaging (BLI) image of the colorectal polyp; Overall high quality of the colorectal polyp image; Availability of the histological results of the colorectal polyp; Minimal age of 18 years old. Exclusion Criteria: Objection to participate in medical scientific research, reported in the medical file; Endoscopic instruments visible at the colorectal polyp image; More than one polyp visible at the colorectal polyp image.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colorectal polyp patients<br>Patients who have a colonoscopy in regular care as part of the Dutch colorectal screening program, in the context of complaints or in the context of the follow-up of previously diagnosed bowel diseases. And who have at least one colorectal polyp found and resected during the examination. | Other: Computer-aided diagnosis (CADx)<br>* Optical diagnosis of colorectal polyps made with computer-aided diagnosis (CADx) using state-of-the-art machine learning methods and deep learning architectures.<br>Other: BLI Adenoma Serrated International Classification (BASIC)<br>* Optical diagnosis of colorectal polyps made with BLI Adenoma Serrated International Classification (BASIC), both by exert endoscopists and novices.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of CADx versus endoscopists | The diagnostic accuracy of characterizing colorectal polyps (into benign versus (pre-)malignant) made by CADx in comparison to the diagnostic accuracy of both expert endoscopists and novices. In which histology is the gold standard. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of BASIC versus intuition | The diagnostic accuracy of both expert endoscopists and novices in characterizing colorectal polyps (into hyperplastic polyp, adenoma, sessile serrated adenoma, or adenocarcinoma) based on the clinical classification model BASIC, in comparison to the diagnostic accuracy based on intuition. In which histology is the gold standard. | 6 months | 
| Diagnostic metrics of CADx | The sensitivity, specificity, negative and positive predictive value of characterizing colorectal polyps (into benign versus (pre-)malignant) made by CADx. | 6 months | 
| AUC of CADx | Area Under ROC Curve (AUC) of CADx for characterizing colorectal polyps (into benign versus (pre-)malignant) made by CADx. | 6 months | 
| Diagnostic metrics of endoscopists | The sensitivity, specificity, negative and positive predictive value of characterizing colorectal polyps (into hyperplastic polyp, adenoma, sessile serrated adenoma, or adenocarcinoma) of both expert endoscopists and novices. | 6 months | 
| Diagnostic metrics of endoscopists for high confidence diagnosis | The diagnostic accuracy, sensitivity, specificity, negative and positive predictive value of both expert endoscopists and novices for optical diagnosis made with high (>90%) confidence. | 6 months | 
| Interobserver agreement | The interobserver agreement of experts, novices and CADx for characterizing colorectal polyps. | 6 months | 
| Computation time of CADx | The computation time per image of CADx for characterizing colorectal polyps. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Artificial intelligence, Computer-aided diagnosis, Optical diagnosis, Colorectal polyps, Blue light imaging