NCT03775811

Brief Summary

Our group, prior to the present study, developed a handcrafted predictive model based on the extraction of surface patterns (textons) with a diagnostic accuracy of over 90%24. This method was validated in a small dataset containing only high-quality images. Artificial intelligence is expected to improve the accuracy of colorectal polyp optical diagnosis. We propose a hybrid approach combining a Deep learning (DL) system with polyp features indicated by clinicians (HybridAI). A pilot in vivo experiment will carried out.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

December 11, 2018

Last Update Submit

January 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the computer-aided system for predicting polyps histology in real clinical practice

    The results of the computer-aided system prediction will be compared with the final pathology report, which is the gold standard

    One year

Interventions

COLONIC POLYP HISTOLOGY PREDICTION IN WHITE LIGHT IMAGES COMBINING ARTIFICIAL INTELLIGENCE AND CLINICAL INFORMATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with polyps of any size/morphology, detected in a routine or screening colonoscopy, that are resected endoscopically and recovered for histological analysis will be included. The images obtained will be used to expand the database.

You may qualify if:

  • Age \> 18 years
  • Approval of participation in the study. Signature of informed consent
  • Patients with at least one polyp of any size/morphology diagnosed in a routine or screening colonoscopy
  • Endoscopies performed with high definition endoscopes

You may not qualify if:

  • Age \<18 years
  • Refusal to participate in the study
  • Polyps partially resected in a previous endoscopy
  • Patients with inflammatory disease
  • Impossibility to wash remains of stool or mucus on the surface of the polyp

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (3)

  • Sanchez-Montes C, Sanchez FJ, Bernal J, Cordova H, Lopez-Ceron M, Cuatrecasas M, Rodriguez de Miguel C, Garcia-Rodriguez A, Garces-Duran R, Pellise M, Llach J, Fernandez-Esparrach G. Computer-aided prediction of polyp histology on white light colonoscopy using surface pattern analysis. Endoscopy. 2019 Mar;51(3):261-265. doi: 10.1055/a-0732-5250. Epub 2018 Oct 25.

    PMID: 30360010BACKGROUND
  • Bernal J, Histace A, Masana M, Angermann Q, Sanchez-Montes C, Rodriguez de Miguel C, Hammami M, Garcia-Rodriguez A, Cordova H, Romain O, Fernandez-Esparrach G, Dray X, Sanchez FJ. GTCreator: a flexible annotation tool for image-based datasets. Int J Comput Assist Radiol Surg. 2019 Feb;14(2):191-201. doi: 10.1007/s11548-018-1864-x. Epub 2018 Sep 25.

    PMID: 30255462BACKGROUND
  • Byrne MF, Chapados N, Soudan F, Oertel C, Linares Perez M, Kelly R, Iqbal N, Chandelier F, Rex DK. Real-time differentiation of adenomatous and hyperplastic diminutive colorectal polyps during analysis of unaltered videos of standard colonoscopy using a deep learning model. Gut. 2019 Jan;68(1):94-100. doi: 10.1136/gutjnl-2017-314547. Epub 2017 Oct 24.

    PMID: 29066576BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 11, 2018

First Posted

December 14, 2018

Study Start

January 1, 2019

Primary Completion

March 31, 2019

Study Completion

December 31, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations