NCT07795476Not yet recruiting
Artificial Intelligence For Outcomes Research in Crohn's Disease: Digital Pathology Assessment of Fibrosis and Association With Patient History and Clinical Outcomes
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 26 Aug 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 15 Mar 2027
- Lead sponsor
- PharmaNest, Inc
- Diseases
- Crohn's disease
- NCT number
- NCT07795476
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Nov 2026 to the primary completion date, 15 Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of gastrointestinal surgery for any indication
Who the study is looking for
- 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)
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hosptal Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| University Hospital Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.