Artificial Intelligence For Outcomes Research in Crohn's Disease: Digital Pathology Assessment of Fibrosis and Association With Patient History and Clinical Outcomes (AIFOR-CD)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Crohn's disease is a chronic inflammatory bowel disease that can lead to progressive intestinal fibrosis. Fibrosis contributes to structural bowel damage, strictures and obstruction and is an important cause of surgical intervention. However, intestinal fibrosis remains difficult to quantify objectively, particularly from routinely collected endoscopic biopsies, and there are limited validated tools to identify tissue fibrosis phenotypes associated with subsequent disease progression.
AIFOR-CD (Artificial Intelligence for Outcomes Research in Crohn's Disease) is a retrospective observational study evaluating the use of artificial intelligence-based digital pathology to quantify and characterize fibrosis in routinely collected ileal biopsies from patients with Crohn's disease.
The study uses the FibroNest Phenotypic Fibrosis Composite Score [Ph-FCS(Muc)], a continuous quantitative digital pathology biomarker derived from histological features of fibrosis measured in the mucosa of ileal biopsies. The study is organized around three complementary objectives: to validate Ph-FCS(Muc) against pathologist-assessed mucosal fibrosis severity; to investigate its relationship with Crohn's disease characteristics and history; and to explore whether quantitative fibrosis phenotypes in ileal biopsies can identify patients at increased risk of subsequent first ileal surgical resection for fibrostenotic Crohn's disease.
The study will use previously collected histological specimens and retrospective clinical information. Digital pathology analyses will be performed using pseudonymized whole-slide images of ileal biopsies, with appropriate blinding between biomarker measurements and the reference assessments or clinical outcomes when applicable.
AIFOR-CD is intended to determine whether quantitative assessment of fibrosis from routinely obtained endoscopic biopsies can provide objective information on intestinal fibrotic burden and contribute to the characterization and risk stratification of patients with Crohn's disease.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Helene Petitjean P. Clinical Study Director, MD
- Número de teléfono: +1 609 375 2003
- Correo electrónico: info@pharmaenst.com
Copia de seguridad de contactos de estudio
- Nombre: Li Chen, Study Director, Ph.D.
- Número de teléfono: +1 609 375 2003
- Correo electrónico: info@pharmaenst.com
Ubicaciones de estudio
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Andalusia
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Seville, Andalusia, España, 41013
- Hospital Universitario Virgen del Rocío
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Contacto:
- Manuel Romero Gomez, MD
- Número de teléfono: +34 955 01 20 00
- Correo electrónico: mromerogomez@us.es
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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.
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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.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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First ileal surgical resection for ileal fibro-stenotic Crohn's
Periodo de tiempo: 24 months
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First ileal surgical resection for ileal fibro-stenotic Crohn's , and No endoscopic procedure (balloon dilation, strictureplasty or stricturectomy)
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24 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Manuel Romero Gomes, MD, Hospital Universitario Virgen del Rocio, Seville Spain
Publicaciones y enlaces útiles
Publicaciones Generales
- Denise Ng et al. (2026). Digital Pathology Quantifies Mucosal Fibrosis and Aligns with Pathologist Scoring in IBD Biopsies; Submitted UEG 2026 (refused on the basis of small N=20) and resubmitted DDW2027
- Chen Li et al. (2026) Evaluation of a Novel Structured, Layer-Specific Framework for Histologic Fibrosis Staging in IBD. Chen L. et Al. Gastrointestinal Endoscopy, Vol. 103, Issue 5, Supplement S-1055-S-1056, May, 2026 - doi. 10.1016/S0016-5107(26)02658-1-
- Miha Jerala, Chen L, Drobne D, Petitjean M, Zidar N. Quantifying fibrosis in inflammatory bowel diseases - contribution of digital pathology. Dig Liver Dis. 2025 Oct;57(10):1938-1946. doi: 10.1016/j.dld.2025.08.002. Epub 2025 Aug 20.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PHN 1-062-26
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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