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

NCT07795476 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-08-31

No results posted yet for this study

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 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

  • Crohn Disease

Interventions

DIAGNOSTIC_TEST

Ph-FCS(Muc) fibrosis severity Digital Pathology biomarker

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.

Sponsors & Collaborators

  • Hospital Universitario Virgen del Rocio, Seville Spain

    collaborator UNKNOWN

  • Hospital Universitario Virgen Macarena Seville, Spain

    collaborator UNKNOWN

  • Hanauer IBD Center at Northwestern Medicine, Chicago, IL, USA

    collaborator UNKNOWN

  • IBD Center, Department of Gastroenterology San Raffaele Hospital, Milan, Italy

    collaborator UNKNOWN

  • PharmaNest, Inc

    lead INDUSTRY

Principal Investigators

  • Manuel Romero Gomes, MD · Hospital Universitario Virgen del Rocio, Seville Spain

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-02-15
Completion
2027-05-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07795476 on ClinicalTrials.gov