AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis (MONET)

November 28, 2024 updated by: University College Cork

A Novel Simplified Endoscopic Score aiMed at Evaluating Ulcerative cOlitis Activity Through TXI, RDI and NBI Vascular Assessment and at prEdicting Clinical Outcome and Its Applicability in an arTificial Intelligence System: the MONET Study

This international multicentre prospective study aims to develop a new simple score using enhanced endoscopic techniques which focus on the vascular features of the colon and reliably distinguish between a quiescent and a mild inflammation in ulcerative colitis (UC). The diagnostic performance of the new score in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes will be evaluated. The study also aims to adapt current artificial intelligence (AI) algorithms for enhanced endoscopic techniques to improve standardization in UC disease assessment and outcome prediction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicentre prospective international study. This study aims at developing a new simple endoscopic score using white light endoscopy - high definition (WLE-HD), Texture and colour enhancement imaging (TXI), red dichromatic imaging (RDI) and narrow-band imaging (NBI) modes, focusing on vascular features to distinguish between quiescent versus patchy mild Ulcerative Colitis. It will evaluate the new score's diagnostic performance in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes. Finally, it also aims to develop and adapt existing artificial intelligence (AI) algorithms according to WLE-HD, TXI, RDI and NBI to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcomes.

The study will be divided in several phases:

  • In the first phase, the score will be developed on the first 30 consecutive virtual electronic chromoendoscopy (VCE) videos (using TXI-RDI and NBI) of UC patients, with different grade of disease activity. Experts in inflammatory bowel disease (IBD) endoscopy will review images and videos from recruited patients to define the endoscopic mucosal and vascular features of the new score. These will be used for a stepwise discussion. A round table discussion using modified Delphi method will be conducted by experts worldwide to ensure equal participation and identify the best component descriptors of endoscopic vascular healing. The components that will achieve 100% consensus will be selected, and the most important endoscopy predictive variables will be confirmed by using a machine learning technique. Finally, a new endoscopic score will be generated. This should be reproducible, valid and responsive.
  • In the second phase, the new endoscopic scoring system will be validated in a large cohort of UC patients, focusing on patients with quiescent disease versus patchy mild colitis. Diagnostic accuracy, interobserver agreement and ability to predict clinical outcome according to the new endoscopic score focused on vascular features assessed with VCE will be evaluated
  • In the third phase, the reproducibility of the new endoscopic scoring system will be evaluated among gastroenterologists with different levels of experience through a short survey and a computerised training module.
  • In the fourth phase, new and existing AI algorithms will be developed and adapted to these endoscopic videos and histological images to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcome in UC.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

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

Study Contact

  • Name: Michelle O'Riordan
  • Phone Number: +353 (0)21 4901759
  • Email: moriordan@ucc.ie

Study Locations

  • Belgium
      • Leuven, Belgium
        • Not yet recruiting
        • University of Leuven
        • Contact:
        • Principal Investigator:
          • Raf Bisschops
  • Germany
  • Ireland
    • Co Cork
      • Cork, Co Cork, Ireland
        • Recruiting
        • University College Cork
        • Contact:
        • Principal Investigator:
          • Marietta Iacucci
  • Italy
      • Bari, Italy
        • Not yet recruiting
        • University of Bari
        • Contact:
        • Principal Investigator:
          • Mariabeatrice Principi
      • Milan, Italy
        • Not yet recruiting
        • Istituto Clinico Humanitas
        • Principal Investigator:
          • Alessandro Armuzzi
        • Contact:
      • Milan, Italy
        • Not yet recruiting
        • University Vita-Salute San Raffaele
        • Principal Investigator:
          • Silvio Danese
        • Contact:
      • Naples, Italy
        • Recruiting
        • University of Naples
        • Contact:
        • Principal Investigator:
          • Olga Maria Nardone
      • Pavia, Italy
        • Not yet recruiting
        • University of Pavia
        • Principal Investigator:
          • Antonio Di Sabatino
        • Contact:
    • Belluno
      • Feltre, Belluno, Italy
        • Not yet recruiting
        • Ospedale S. Maria del Prato
        • Contact:
        • Principal Investigator:
          • Andrea Buda
  • Japan
      • Tokyo, Japan
  • Singapore
      • Singapore, Singapore
        • Not yet recruiting
        • Changi General Hospital
        • Contact:
        • Principal Investigator:
          • Kimg Tan Chin

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Males and females between 18 and 75 years old with an established diagnosis of UC, who have undergone colonoscopy for disease assessment and surveillance will be consecutively recruited after obtaining written consent. The sample size in 300.

Description

Inclusion Criteria:

  • Adult patients aged 18 to 75 years old
  • Established diagnosis of UC (for at least six months in duration), independently from their active treatment
  • Undergoing endoscopy for disease activity assessment or cancer surveillance.

Exclusion Criteria:

  • Contraindications to endoscopy (including toxic megacolon) and biopsies (including severe coagulopathy/thrombocytopenia)
  • Poor bowel preparation (defined as total BBPS <6 or BBPS <2 in observed segment for sigmoidoscopy)
  • Significant co-morbidities limiting life expectancy and conferring high risk of endoscopy
  • Pregnant and breast-feeding subjects
  • Inability to provide informed consent
  • If the participant has been in a recent experimental trial, these must have been completed not less than thirty days prior to this study

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ulcerative Colitis patients
UC patients who have been scheduled for colonoscopy for disease assessment or surveillance
Procedure: Colonoscopy after bowel cleansing
Colonoscopy will be performed using HD-WLE; TXI; RDI and NBI.
Procedure: Intestinal biopsies
During colonoscopy, at least 2 biopsies from each segment will be taken as standard of care to assess inflammation in UC
Diagnostic test: blood sampling
Blood samples will be taken for standard of care by appropriately trained members of the clinical research team. The results of the standard of care blood will be used in the research.
Diagnostic test: Stool
The stool sample will be sent to the laboratory for Faecal Calprotectin (FCP) as a marker of disease activity.
Other: Clinical follow-up
Patients will be followed-up at 6 and 12 months after index endoscopy. Patients will be evaluated in clinic or by telephone call and the disease will be reassessed. Partial Mayo Score (PMS) and occurrence of clinical outcomes will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of the new scoring system
Time Frame: 6 months
To evaluate the diagnostic performance of the new score in evaluating endoscopic and histological activity
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation with existing score
Time Frame: 2 years
To evaluate the new score's diagnostic performance in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes
2 years
AI development
Time Frame: 2 years
Develop and adapt existing AI algorithms according to WLE-HD, TXI, RDI and NBI to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcomes in UC
2 years

Collaborators and Investigators

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

Sponsor

University College Cork

Collaborators

Olympus

Investigators

  • Principal Investigator: Marietta Iacucci, MD, University College Cork

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

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)

November 4, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APC193

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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