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Artificial Intelligence For Outcomes Research in Crohn's Disease: Digital Pathology Assessment of Fibrosis and Association With Patient History and Clinical Outcomes
Sponsor: PharmaNest, Inc
Summary
The goal of this retrospective observational study is to learn whether artificial intelligence-based digital pathology can measure intestinal fibrosis and help identify patients with Crohn's disease who may be at greater risk of disease progression and surgery. The main questions the study aims to answer are: Does the FibroNest Phenotypic Fibrosis Composite Score \[Ph-FCS(Muc)\], measured from routinely collected ileal biopsies, reflect the severity of fibrosis assessed by a pathologist? * Is Ph-FCS(Muc) associated with Crohn's disease characteristics and history? * Can Ph-FCS help predict whether a patient will subsequently require a first ileal surgical resection for fibrostenotic Crohn's disease? Researchers will retrospectively analyze previously collected ileal biopsies and medical information from adults with Crohn's disease. Biopsy slides will be digitized and analyzed using FibroNest digital pathology, and the resulting fibrosis measurements will be compared with pathologist assessments, clinical characteristics, disease history, and subsequent clinical outcomes.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2026-10-01
Completion Date
2027-05-15
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
Ph-FCS(Muc) fibrosis severity Digital Pathology biomarker
Ph-FCS(Muc) is a continuous, quantitative digital pathology biomarker that integrates multiple histological features of mucosal fibrosis into a single fibrosis severity score, providing a more granular assessment than conventional ordinal histological staging.
Locations (1)
Hospital Universitario Virgen del Rocio
Seville, Andalusia, Spain