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
Study ID
NCT07795476
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ph-FCS(Muc) fibrosis severity Digital Pathology biomarker — DIAGNOSTIC_TEST
    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.

Study Details

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 Dates

First listed
Aug 31, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Feb 15, 2027
Completion
May 15, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Patients with surgical intervention 6-24 Months after index biopsy
    Patients with with CD and ileal biopsy that underwent a first ileal surgical resection for ileal fibro-stenotic Crohn's disease within a minimum of 6 months and a maximum of 24 months after the index biopsy. No endoscopic procedure (balloon dilation, strictureplasty or stricturectomy) is permitted between the index biopsy and the first ileal surgical resection.
  • Arm: Patients without surgical intervention within 4 years after index biopsy
    Patients with CD and ileal biopsy that did NOT undergo first ileal resection or ileal endoscopic procedure (balloon dilation, strictureplasty or stricturectomy) within 4 years after the index biopsy.

Primary Outcome Measure

First ileal surgical resection for ileal fibro-stenotic Crohn's [ Time Frame: 24 months ]

Central Contacts

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