Artificial Intelligence For Outcomes Research in Crohn's Disease: Digital Pathology Assessment of Fibrosis and Association With Patient History and Clinical Outcomes

Study acronym: AIFOR-CD
StatusNot Yet Recruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary endpoint(s) modified Show 4 more changesShow less
    • Start date pushed from Oct 1, 2026 to Nov 1, 2026
    • Study sites: 1 to 2
    • Primary completion date: Feb 15, 2027 to Mar 15, 2027
    • Collaborators: 4 to 3
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07795476
Lead Sponsor PharmaNest, Inc
Collaborators: University Hospital of Nuestra Señora de Valve, University Hospital of Virgen del Rocio, University Hospital of Virgen Macarena
Conditions
(from sponsor)		 Crohn Disease, Fibrostenotic Crohn's Disease, CD - Crohn's Disease
Related terms Crohn Disease, Fibrosis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov