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

NCT06709209 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-12-03

No results posted yet for this study

Summary

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.

Conditions

  • Ulcerative Colitis (UC)

Interventions

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.

Sponsors & Collaborators

  • Olympus

    collaborator INDUSTRY

  • University College Cork

    lead OTHER

Principal Investigators

  • Marietta Iacucci, MD · University College Cork

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2026-09-30
Completion
2027-09-30

Countries

  • Belgium
  • Germany
  • Ireland
  • Italy
  • Japan
  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06709209 on ClinicalTrials.gov