Artificial Intelligence For Outcomes Research in Crohn's Disease: Digital Pathology Assessment of Fibrosis and Association With Patient History and Clinical Outcomes (AIFOR-CD)
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Crohn's disease is a chronic inflammatory bowel disease that can lead to progressive intestinal fibrosis. Fibrosis contributes to structural bowel damage, strictures and obstruction and is an important cause of surgical intervention. However, intestinal fibrosis remains difficult to quantify objectively, particularly from routinely collected endoscopic biopsies, and there are limited validated tools to identify tissue fibrosis phenotypes associated with subsequent disease progression.
AIFOR-CD (Artificial Intelligence for Outcomes Research in Crohn's Disease) is a retrospective observational study evaluating the use of artificial intelligence-based digital pathology to quantify and characterize fibrosis in routinely collected ileal biopsies from patients with Crohn's disease.
The study uses the FibroNest Phenotypic Fibrosis Composite Score [Ph-FCS(Muc)], a continuous quantitative digital pathology biomarker derived from histological features of fibrosis measured in the mucosa of ileal biopsies. The study is organized around three complementary objectives: to validate Ph-FCS(Muc) against pathologist-assessed mucosal fibrosis severity; to investigate its relationship with Crohn's disease characteristics and history; and to explore whether quantitative fibrosis phenotypes in ileal biopsies can identify patients at increased risk of subsequent first ileal surgical resection for fibrostenotic Crohn's disease.
The study will use previously collected histological specimens and retrospective clinical information. Digital pathology analyses will be performed using pseudonymized whole-slide images of ileal biopsies, with appropriate blinding between biomarker measurements and the reference assessments or clinical outcomes when applicable.
AIFOR-CD is intended to determine whether quantitative assessment of fibrosis from routinely obtained endoscopic biopsies can provide objective information on intestinal fibrotic burden and contribute to the characterization and risk stratification of patients with Crohn's disease.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Helene Petitjean P. Clinical Study Director, MD
- Numer telefonu: +1 609 375 2003
- E-mail: info@pharmaenst.com
Kopia zapasowa kontaktu do badania
- Nazwa: Li Chen, Study Director, Ph.D.
- Numer telefonu: +1 609 375 2003
- E-mail: info@pharmaenst.com
Lokalizacje studiów
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Andalusia
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Seville, Andalusia, Hiszpania, 41013
- Hospital Universitario Virgen del Rocío
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Kontakt:
- Manuel Romero Gomez, MD
- Numer telefonu: +34 955 01 20 00
- E-mail: mromerogomez@us.es
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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Patients with surgical intervention 6-24 Months after index biopsy
Patients with with CD and ileal biopsy that underwent a first ileal surgical resection for ileal fibro-stenotic Crohn's disease within a minimum of 6 months and a maximum of 24 months after the index biopsy.
No endoscopic procedure (balloon dilation, strictureplasty or stricturectomy) is permitted between the index biopsy and the first ileal surgical resection.
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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.
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Patients without surgical intervention within 4 years after index biopsy
Patients with CD and ileal biopsy that did NOT undergo first ileal resection or ileal endoscopic procedure (balloon dilation, strictureplasty or stricturectomy) within 4 years after the index biopsy.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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First ileal surgical resection for ileal fibro-stenotic Crohn's
Ramy czasowe: 24 months
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First ileal surgical resection for ileal fibro-stenotic Crohn's , and No endoscopic procedure (balloon dilation, strictureplasty or stricturectomy)
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24 months
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Manuel Romero Gomes, MD, Hospital Universitario Virgen del Rocio, Seville Spain
Publikacje i pomocne linki
Publikacje ogólne
- Denise Ng et al. (2026). Digital Pathology Quantifies Mucosal Fibrosis and Aligns with Pathologist Scoring in IBD Biopsies; Submitted UEG 2026 (refused on the basis of small N=20) and resubmitted DDW2027
- Chen Li et al. (2026) Evaluation of a Novel Structured, Layer-Specific Framework for Histologic Fibrosis Staging in IBD. Chen L. et Al. Gastrointestinal Endoscopy, Vol. 103, Issue 5, Supplement S-1055-S-1056, May, 2026 - doi. 10.1016/S0016-5107(26)02658-1-
- Miha Jerala, Chen L, Drobne D, Petitjean M, Zidar N. Quantifying fibrosis in inflammatory bowel diseases - contribution of digital pathology. Dig Liver Dis. 2025 Oct;57(10):1938-1946. doi: 10.1016/j.dld.2025.08.002. Epub 2025 Aug 20.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- PHN 1-062-26
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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