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(Muc) 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.
Adult pts (>=18 years old) diagnosed with Crohn's disease based on Investigator's assessment.
Ileal biopsy with fibrosis Masson's Trichome staining available for digitization or already digitized at 40X ( or ~0.25micron per pixel)
The cohort will contain patients with various levels of intensity and distribution of fibrosis as defined by the pathologist with a minimum of 7 patients for any level of intensity and distribution for being required.
Minimum information available for each patient (see Appendix 2, table 1)
History of gastrointestinal endoscopic interventions and/or surgery for Crohn's disease management such as endoscopic balloon dilation, strictureplasty, stricturectomy or bowel resection prior to the index biopsy.
History of gastrointestinal surgery for any indication
The study population consists of adults (≥18 years) with a diagnosis of Crohn's disease and an available ileal endoscopic biopsy suitable for digital pathology analysis. The overall AIFOR-CD population includes patients spanning varying degrees of mucosal fibrosis and disease characteristics. For the outcomes component, patients without prior gastrointestinal surgery or endoscopic intervention are selected according to whether they underwent a first ileal surgical resection for fibrostenotic Crohn's disease within 6-24 months after the index biopsy or remained free of ileal resection or endoscopic intervention for at least 4 years after the index biopsy.
Cohort
Retrospective
Ph-FCS(Muc) fibrosis severity Digital Pathology biomarker
Diagnostic testPh-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.
Occurrence of the First ileal surgical resection for ileal fibro-stenotic Crohn's
Occurrence (and date of occurrence) of the First ileal surgical resection for ileal fibro-stenotic Crohn's , and No endoscopic procedure (balloon dilation, strictureplasty or stricturectomy)
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PharmaNest, Inc
Lead sponsor
University Hospital of Nuestra Señora de Valve
Collaborator
University Hospital of Virgen del Rocio
Collaborator
University Hospital of Virgen Macarena
Collaborator
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