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Accuracy of CADx System for White Light Colonic Polyp Characterization (GIC)

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ClinicalTrials.gov Identifier: NCT05492656
Recruitment Status : Recruiting
First Posted : August 8, 2022
Last Update Posted : August 16, 2022
Sponsor:
Information provided by (Responsible Party):
Franco Radaelli, Valduce Hospital

Brief Summary:
The endoscopist performances in the optical diagnosis (OD) of colonic polyps with the available technologies vary widely across centers and across endoscopists. The OD process is strictly related to the operator training and expertise. Most of the available studies in optical characterization have been carried out by expert endoscopist in tertiary high volume centers, and weren't replied on large unselected populations. For these reasons, at the moment the optical characterization of polypoid lesions can't replace, in the everyday clinical practice, the histopathological evaluation of resected polyps. Artificial intelligence (AI)-based systems have the potential to make optical characterization process of colonic polyps easier and more reliable, thus supporting the endoscopist in the application of leave-in-situ and of resect-and-discard strategies. The implementation of such strategies would lead to a significant economic saving and a decrease of risks and complications related to unnecessary polypectomy. GI-Genius System (Medtronic Inc, Minneaopolis, USA) is a CNN-based algorithm allowing an automatic OD of colonic polyps. This system does not require dedicated light setting for polyp evaluation as it works with white light high definition images, which are the actual standard in every endoscopic unit. During colonoscopy, when a polyp is framed within the screen, a green detection box surrounds the polyp and the system automatically provides (whenever possible) the optical diagnosis labeling the polyp as "adenoma or non-adenoma". When the automatic polyp charaterization is unfeasible the label "no prediction" appears. Nowadays only few data about the feasibility and performances of this system in clinical practice are available. In addition published studies are mostly focused on technical rather thann clinical issues. The present prospective observational trial is primarily aimed at evaluating the diagnostic accuracy of optical characterization of colonic polyps <= 1 cm using GI-Genius System in daily clinical practice, having histopathology examination as reference standard.

Condition or disease
Colonic Polyp Adenoma Colon

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Accuracy and Feasibility of CADx System for White Light Colonic Polyp Characterization
Actual Study Start Date : August 5, 2022
Estimated Primary Completion Date : November 5, 2022
Estimated Study Completion Date : November 5, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Polyps




Primary Outcome Measures :
  1. Diagnostic accuracy of CADx in evaluating small colonic polyps [ Time Frame: Entire study duration (3 months) ]
    Numer of correctly characterized polyps using AI/total number of detected polyps


Secondary Outcome Measures :
  1. Feasibility of CADx in evaluating small colonic polyps [ Time Frame: Entire study duration (3 months) ]
    Number of characterizable polyps using AI/total number of detected polyps

  2. Sensitivity [ Time Frame: Entire study duration (3 months) ]
    CADx sensitivity (rate of TP/TP+FN) will be calculated having histopathology as reference standard and according to polyp size and location

  3. specificity [ Time Frame: Entire study duration (3 months) ]
    CADx specificity (rate of TN/TN+FP) will be calculated having histopathology as reference standard according to polyp size and location

  4. Positive predictive value [ Time Frame: Entire study duration (3 months) ]
    CADx positive predictive value (rate of TP/TP+FP) will be calculated having histopathology as reference standard according to polyp size and location

  5. Negative predictive value [ Time Frame: Entire study duration (3 months) ]
    CADX negative predictive value (rate of TN/TN+FN) will be calculated having histopathology as reference standard according to polyp size and location



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive adults (18-85 years) outpatients referred for colonoscopy are invited to participate in the present study.
Criteria

Inclusion Criteria:

Consecutive outpatients undergoing colonoscopy for one of the following indication:

  • FIT-based screening program
  • voluntary screening
  • post-polipectomy surveillance
  • gastrointestinal symptoms
  • family history of colorectal cancer.

Exclusion Criteria:

  • urgent colonoscopy
  • patients in which polyps could not be resected (e.g ongoing anticoagulation therapy)
  • patients with past colorectal cancer or polyposis syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05492656


Contacts
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Contact: Franco Radaelli, MD 0039031324147 francoradaelli01@gmail.com
Contact: Emanuele Rondonotti, MD 0039031324147 ema.rondo@gmail.com

Locations
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Italy
Gastroenterology Unit, Valduce Hospital Recruiting
Como, Italy, 22100
Contact: Franco Radaelli, MD    0039031324145    francoradaelli01@gmail.com   
Sponsors and Collaborators
Valduce Hospital
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Responsible Party: Franco Radaelli, Head of Gastroenterology Unit, Valduce Hospital
ClinicalTrials.gov Identifier: NCT05492656    
Other Study ID Numbers: 41/2022
First Posted: August 8, 2022    Key Record Dates
Last Update Posted: August 16, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Polyps