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

RecruitingOBSERVATIONAL
Enrollment

300

Participants

Timeline

Start Date

November 4, 2024

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2027

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.

Trial Locations (11)

Unknown

NOT_YET_RECRUITING

University of Leuven, Leuven

NOT_YET_RECRUITING

Klinikum Luneburg, Lüneburg

RECRUITING

University College Cork, Cork

NOT_YET_RECRUITING

Ospedale S. Maria del Prato, Feltre

NOT_YET_RECRUITING

University of Bari, Bari

NOT_YET_RECRUITING

Istituto Clinico Humanitas, Milan

NOT_YET_RECRUITING

University Vita-Salute San Raffaele, Milan

RECRUITING

University of Naples, Naples

NOT_YET_RECRUITING

University of Pavia, Pavia

NOT_YET_RECRUITING

Showa University, Tokyo

NOT_YET_RECRUITING

Changi General Hospital, Singapore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Olympus

INDUSTRY

lead

University College Cork

OTHER

NCT06709209 - AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis | Biotech Hunter | Biotech Hunter