Clinical Validation of PolyDeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System. Polydeep Advance 3

Study Overview
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Brief Summary
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This study is a clinical validation of PolyDeep, a computer-aided polyp detection (CADe) and characterization (CADx) system. PolyDeep Advance 3 is a multicentric randomized clinical trial comparing high definition colonoscopy with PolyDeep assisted high definition colonoscopy. The hypothesis of the study is that the PolyDeep assisted colonoscopy increases the Adenoma Detection Rate (ADR).

Detailed Description
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Colorectal cancer (CRC) is the most frequently cancer in western world. A fundamental tool for detection and prevention is the colonoscopy. The detection and endoscopic resection of colorectal polyps, the precursor lesion of CRC, can reduce CRC incidence and mortality. Adenoma Detection Rate is the most used endoscopic quality indicator. The improvement of this indicator is related to the reduction of postcolonoscopy CRC incidence and mortality. Colorectal polyp diagnosis is based on endoscopic resection and histological analysis. An accurate optical diagnosis could avoid histological lesion of smaller lesions, reducing the costs associated with histological diagnosis. The NICE (NBI International Colorectal Endoscopic) Classification has proposed use high definition endoscopes that have Narrow Band Imaging (NBI). However, NICE must be used by endoscopists who are sufficiently prepared and who have overcome the learning curve. Therefore, optical histology diagnosis with high accuracy independently of the center and the endoscopist is necessary. Computer Aid Diagnosis (CAD) systems based on Artificial Intelligence are experiencing exponential development in the field of medical image analysis. The development of the CAD system is based on the creation of large databases of endoscopic images and/or videos, on the training, development and validation of diagnostic algorithms in such databases and, finally, on prospective clinical validation in patients undergoing colonoscopy. The goal of CAD systems in colonoscopy is double. First, the CAD system aims to increase the detection of polyps (CADe) in general, and of adenomas and serrated lesions in particular. The second objective is to characterize (CADx) the histology of detected lesion. PolyDeep CAD is a functional prototype. This CAD system is capable of detecting, locating and classifying colorectal polyps. In vivo validation data shows that PolyDeep has high diagnostic accuracy for polyp identification and that this accuracy can be accommodated. The aim of PolyDeep advance 3 is to compare Adenoma Detection Rate differences in a randomized clinical trial. The investigators will compare the Adenoma Detection Rate between high definition colonoscopy and PolyDeep assisted high definition colonoscopy, both in CRC screening and surveillance.

Official Title
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PolyDeep Advance 3: Randomized Clinical Trial Comparing High Definition Colonoscopy With PolyDeep Assisted High Definition Colonoscopy.

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: High definition colonoscopy (standard colonoscopy) in Adenoma Detection Rate
* Diagnostic Test: PolyDeep assisted high definition colonoscopy (CAD system) in Adenoma Detection Rate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First diagnostic colonoscopy performed after a positive fecal immunochemical test performed within the CRC screening program. Surveillance after resection of colorectal adenomas Acceptance after reading the information sheet and signing informed consent. Exclusion Criteria: Colonoscopies with insufficient intestinal cleansing (Boston Bowel Preparation Scale <6 or <2 in any of the evaluated segments). Incomplete colonoscopy without cecal intubation. Previous CRC Previous colonic resection. Hereditary CRC syndromes Serrated polyposis syndrome

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients who fulfill criteria will be randomly allocated to high definition colonoscopy or Polydeep assisted high definition colonoscopy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control arm: High definition colonoscopy<br>Diagnostic test: Standard colonoscopy | Diagnostic Test: High definition colonoscopy (standard colonoscopy) in Adenoma Detection Rate<br>* In the intervention of this arm the investigators will apply the standard colonoscopy without computer-aided colonoscopy (polyDeep)<br>|
| Experimental: PolyDeep assisted high definition colonoscopy<br>Diagnostic test: PolyDeep | Diagnostic Test: PolyDeep assisted high definition colonoscopy (CAD system) in Adenoma Detection Rate<br>* In the intervention of this arm the investigators will apply polyDeep assisted high definition colonoscopy (CAD system).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Detection Rate (ADR) | Number of colonoscopies with adenomas/total number of colonoscopies. The investigators will evaluate if there are differences between both arms. | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection rate | Number of colonoscopies with polyps/total number of colonoscopies. The investigators will evaluate if there are differences between both arms. | 1.5 years | 
| Serrated lesion detection rate | Number of colonoscopies with serrated lesions/total number of colonoscopies. The investigators will evaluate if there are differences between both arms. | 1.5 years | 
| Advanced lesion detection rate | Number of colonoscopies with advanced lesions (adenomas≥10mm, villous histology or high grade dysplasia; serrated lesions with dysplasia or ≥10mm) /total number of colonoscopies. The investigators will evaluate if there are differences between both arms. | 1.5 years | 
| Withdrawal time: | Withdrawal time between the two arms will be calculated and compared by the investigators | 1.5 years | 
| Characterization of the detected lesions. | The investigators will evaluate the optical diagnosis accuracy of Polydeep for the final histological diagnosis (sensitivity, specificity, positive and negative predictive values). | 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal adenomas, Colorectal polyps, Serrated lesions, Polydeep, computer-aided System