Assessing Severity of Disease in Patients with Ulcerative Colitis.
Baldeep Singh Pabla, David Allen Schwartz
https://pubmed.ncbi.nlm.nih.gov/33121688/Actively Recruiting
Led by University College Cork · Updated on 2024-12-03
300
Participants Needed
11
Research Sites
52 weeks
Total Duration
Researchers are conducting an international multicenter study to develop a new simplified endoscopic score focused on vascular features of the colon to distinguish between inactive and mild inflammation in ulcerative colitis UC. This study aims to compare the new scores ability to define disease activity and remission against existing endoscopic and histological scores, as well as to predict long-term clinical outcomes. Additionally, the study seeks to adapt artificial intelligence AI algorithms to enhance disease assessment and outcome prediction using various enhanced endoscopic techniques. The study will use high-definition white light endoscopy WLE-HD along with texture and colour enhancement imaging TXI, red dichromatic imaging RDI, and narrow-band imaging NBI modes. It includes several phases developing the score using video analysis and expert consensus, validating it in a large group of UC patients, assessing its reproducibility among gastroenterologists, and creating AI algorithms to standardize grading and prediction. Patients undergoing colonoscopy for disease assessment or surveillance will have colonoscopy with biopsies, blood and stool samples taken to monitor inflammation. Participants will be followed up at 6 and 12 months with clinic or telephone assessments to evaluate disease activity using the Partial Mayo Score and clinical outcomes. Researchers will analyze the diagnostic performance of the new score within six months and correlate it with existing scores and AI developments over two years. The study involves collecting clinical data, imaging, biopsies, blood, and stool samples to thoroughly assess and predict UC disease activity and outcomes.
CONDITIONS
AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis
M
Michelle O'Riordan
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University College Cork
Lead Sponsor
Olympus
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Day of colonoscopy
Participants undergo colonoscopy with advanced imaging techniques and biopsies to assess disease activity and collect samples for research.
1 visit (in-person) for colonoscopy and sample collection
Duration - 12 months
Participants are followed up at 6 and 12 months to assess disease status and clinical outcomes using clinical evaluations and questionnaires.
2 visits (in-person or telephone) at 6 and 12 months post-colonoscopy
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/36228649/University College Cork
Lead Sponsor
Olympus
Collaborating Sponsor