ClinicalTrials.gov
Cure8 trial brief
Why This Matters
AIFOR-CD aims to validate an AI-derived digital pathology score that could objectively measure intestinal fibrosis from routine ileal biopsies.
If successful and validated, such a biomarker might help identify Crohn’s patients at higher risk of fibrostenotic progression and need for surgery, improving risk stratification.
Who Should Pay Attention
Researchers and clinicians focused on IBD biomarkers and digital pathology; patients and caregivers interested in tools to predict fibrostenotic Crohn’s disease progression.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment100 participants
Study statusNot_yet_recruiting
Source depthTrial registry record
What To Know
This ClinicalTrials.gov record describes AIFOR-CD, a retrospective observational study testing an AI-based digital pathology biomarker (the FibroNest Ph-FCS(Muc)) to quantify mucosal fibrosis in archived ileal biopsy slides from adults with Crohn’s disease.
Researchers will digitize trichrome-stained slides, measure fibrosis with the FibroNest algorithm, compare those measurements to pathologist assessments and clinical history, and examine whether the metric is associated with later need for first ileal resection for fibrostenotic disease.
The study uses previously collected biopsies and retrospective clinical records, with blinding between the biomarker measurements and reference assessments or outcomes. Planned enrollment is about 100 patients; registry status is Not Yet Recruiting and the single listed site is in Seville, Spain.
The focus is on developing and validating a quantitative histologic biomarker (Ph-FCS[Muc]) that might help identify patients at higher risk of fibrostenotic progression and surgery. This is not an interventional drug trial; it’s a diagnostic/biomarker validation using AI applied to archived pathology slides.
Keep In Mind
Retrospective observational study using previously collected biopsies and records; registry status is Not Yet Recruiting. The entry describes planned analyses but does not present results; findings would require external validation before changing care.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorPharmaNest, Inc
Trial IDNCT07795476
Study typeObservational
Enrollment100 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 31, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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