Artificial Intelligence and Dysplasia Detection in Ulcerative Colitis (CUDISIA Study) (CUDISIA)

June 8, 2024 updated by: Antonio López-Serrano, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Impact of Artificial Intelligence in Dysplasia Detection During Colonoscopy in Patients With Long-data Ulcerative Colitis: a Crossover Study

Prospective clinical study that analyzes the efficacy of colonoscopy assisted by an artificial intelligence system (DiscoveryTM) compared to virtual chromoendoscopy with iSCAN in the detection of colon dysplasia in patients with long-standing Ulcerative Colitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46017
        • Antonio López-Serrano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ulcerative Colitis confirmed by endoscopy and histology.
  • Involvement 30% of the colonic surface (or any extent if concomitant with PSC).
  • Duration of the disease >7 years (or any duration if concomitant with PSC).

Exclusion Criteria:

  • Personal history of colorectal cancer or high-grade dysplasia.
  • Previous colectomy (partial or complete).
  • Coagulopathy that prevents biopsies or polypectomy.
  • Colonoscopy performed in the previous 6 months.
  • Pregnant or nursing women.
  • Inadequate bowel preparation.
  • Presence of endoscopic Ulcerative Colitis activity.
  • Colonic stenosis and incomplete colonoscopy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Colonoscopy assisted by DiscoveryTM
Device: DiscoveryTM
Colonoscopy assisted by an artificial intelligence system (DiscoveryTM).
Active Comparator: Virtual Colonoscopy with iSCAN
Device: iSCAN
Virtual colonoscopy assisted by iSCAN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Per lesion" dysplasia detection rate (DDR)
Time Frame: Immediately after the procedure.
Proportion of dysplastic lesions in relation to all the lesions analyzed that were detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN in patients with long-standing Ulcerative Colitis who undergo surveillance colonoscopy.
Immediately after the procedure.
"Per patient" dysplasia detection rate (DDR)
Time Frame: Immediately after the procedure.
Proportion of patients with dysplastic lesions in relation to all the patients with long-standing Ulcerative Colitis included in the study detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN.
Immediately after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Collaborators

University of Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Actual)

May 18, 2021

Study Completion (Actual)

May 18, 2021

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

December 17, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 8, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIm: 62.21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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