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

NCT07795476 | Not Yet Recruiting

• 1 other identifier: PHN 1-062-26
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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(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.

Conditions

Fibrostenotic Crohn's Disease; CD - Crohn's Disease; Crohn Disease

Keywords

Digital Pathology; Fibrosis; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• 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)

  24 months

Study Arms (2)

Patients with surgical intervention 24 Months after index biopsy

Patients with with Crohn's Disease (CD) and ileal biopsy that underwent a first ileal surgical resection for ileal fibro-stenotic Crohn's disease within 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.

Diagnostic Test: Ph-FCS(Muc) fibrosis severity Digital Pathology biomarker

Patients without surgical intervention within 4 years after index biopsy

Patients with Crohn's Disease 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.

Diagnostic Test: Ph-FCS(Muc) fibrosis severity Digital Pathology biomarker

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.

Patients with surgical intervention 24 Months after index biopsy; Patients without surgical intervention within 4 years after index biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Virgen del Rocio: collaborator
• University Hospital of Virgen Macarena: collaborator
• University Hospital of Nuestra Señora de Valve: collaborator
• PharmaNest, Inc: lead

Study Sites (2)

University Hospital Virgen del Rocio

Seville, Andalusia, 41013, Spain

Location

University Hosptal Virgen Macarena

Seville, Spain

Location

Related Publications (3)

• 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

  BACKGROUND

• 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-

  BACKGROUND

• 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.

  PMID: 40841237 RESULT

MeSH Terms

Conditions

Crohn Disease; Fibrosis

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel Romero Gomes, MD

  Hospital Universitario Virgen del Rocio, Seville Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helene Petitjean P. Clinical Study Director, MD

CONTACT

+1 609 375 2003; info@pharmaenst.com

Li Chen, Study Director, Ph.D.

CONTACT

+1 609 375 2003; info@pharmaenst.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

ES (2)