Computer analysis of gut biopsies to measure scarring in Crohn's disease
Tests computer analysis of past gut biopsies for scarring in adults with Crohn's.
Plain-language title generated from the registry record
Registry title: Artificial Intelligence For Outcomes Research in Crohn's Disease: Digital Pathology Assessment of Fibrosis and Association With Patient History and Clinical Outcomes
Key facts
- Where
- Seville, SpainSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07795476, who can take part
Where in Spain
- University Hospital Virgen del RocioSeville, SpainNo longer taking part
- University Hosptal Virgen MacarenaSeville, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- PharmaNest, Inc
- Trial code
- NCT07795476
- Record updated
- 1 October 2026
- Original description
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.Read full original descriptionShow less
Artificial Intelligence For Outcomes Research in Crohn's Disease: Digital Pathology Assessment of Fibrosis and Association With Patient History and Clinical Outcomes
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.
Inclusion: 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: 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.