Crohn'sNot yet recruiting
Artificial Intelligence For Outcomes Research in Crohn's Disease: Digital Pathology Assessment of Fibrosis and Association With Patient History and Clinical Outcomes
Observational · No treatment assigned · 2 sites · PharmaNest, Inc
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease, Fibrostenotic Crohn's Disease and CD - Crohn's Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- 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)
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- The study has 2 groups.
- Start date: 2026-11-01 (planned).
- Main results expected around 2027-03-15 (estimate from the record).
- 2 study sites listed in Spain.
Groups in this study
- Patients with surgical intervention 24 Months after index biopsy
- Patients without surgical intervention within 4 years after index biopsy
Main thing being measured
- Occurrence of the First ileal surgical resection for ileal fibro-stenotic Crohn's (24 months)
In the researchers’ words
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…
Words you might see
- Endoscopy: a camera exam inside the digestive tract.
- Stricture: a narrowing (of the bowel or of a bile duct).
- Biopsy / histology: a small tissue sample examined under a microscope.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease; Fibrostenotic Crohn's Disease; CD - Crohn's Disease |
| Lead sponsor | PharmaNest, Inc |
| Collaborators | University Hospital of Nuestra Señora de Valve; University Hospital of Virgen del Rocio; University Hospital of Virgen Macarena |
| Enrollment | 100 (estimated) |
| Start date | 2026-11-01 |
| Primary completion (est.) | 2027-03-15 |
| First posted | 2026-08-31 |
| Last updated | 2026-10-01 |
| Official title | Artificial Intelligence For Outcomes Research in Crohn's Disease: Digital Pathology Assessment of Fibrosis and Association With Patient History and Clinical Outcomes |
| ClinicalTrials.gov ID | NCT07795476 |
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.
Full eligibility criteria (from the record)
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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| University Hosptal Virgen Macarena | Seville | Spain | |
| University Hospital Virgen del Rocio | Seville, Andalusia | Spain |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.