[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654022":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":19,"interventions":29,"overallOfficials":35,"centralContacts":40,"locations":48,"responsibleParty":77,"collaborators":79,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":13,"studyType":100,"phases":13,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":110,"whyStopped":13,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"PharmaNest, Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Occurrence of the First ileal surgical resection for ileal fibro-stenotic Crohn's","Occurrence (and date of occurrence) of the First ileal surgical resection for ileal fibro-stenotic Crohn's , and No endoscopic procedure (balloon dilation, strictureplasty or stricturectomy)","24 months",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","RETROSPECTIVE","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.\n\nAIFOR-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.\n\nThe 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.\n\nThe 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.\n\nAIFOR-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.","The study population consists of adults (≥18 years) with a diagnosis of Crohn's disease and an available ileal endoscopic biopsy suitable for digital pathology analysis. The overall AIFOR-CD population includes patients spanning varying degrees of mucosal fibrosis and disease characteristics. For the outcomes component, patients without prior gastrointestinal surgery or endoscopic intervention are selected according to whether they underwent a first ileal surgical resection for fibrostenotic Crohn's disease within 6-24 months after the index biopsy or remained free of ileal resection or endoscopic intervention for at least 4 years after the index biopsy.",[20,25],{"label":21,"type":13,"description":22,"interventionNames":23},"Patients with surgical intervention 24 Months after index biopsy","Patients with with Crohn's Disease (CD) and ileal biopsy that underwent a first ileal surgical resection for ileal fibro-stenotic Crohn's disease within 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.",[24],"Diagnostic Test: Ph-FCS(Muc) fibrosis severity Digital Pathology biomarker",{"label":26,"type":13,"description":27,"interventionNames":28},"Patients without surgical intervention within 4 years after index biopsy","Patients with Crohn's Disease 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.",[24],[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":13},"DIAGNOSTIC_TEST","Ph-FCS(Muc) fibrosis severity Digital Pathology biomarker","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.",[21,26],[36],{"name":37,"affiliation":38,"role":39},"Manuel Romero Gomes, MD","Hospital Universitario Virgen del Rocio, Seville Spain","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":13,"email":45},"Helene Petitjean P. Clinical Study Director, MD","CONTACT","+1 609 375 2003","info@pharmaenst.com",{"name":47,"role":43,"phone":44,"phoneExt":13,"email":45},"Li Chen, Study Director, Ph.D.",[49,67],{"facility":50,"status":13,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University Hospital Virgen del Rocio","Seville","Andalusia","41013","Spain","ES",{"type":57,"coordinates":58},"Point",[59,60],-5.97317,37.38283,{"lat":60,"lon":59},[63],{"name":64,"role":43,"phone":65,"phoneExt":13,"email":66},"Manuel Romero Gomez, MD","+34 955 01 20 00","mromerogomez@us.es",{"facility":68,"status":13,"city":51,"state":13,"zip":13,"country":54,"countryCode":55,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"University Hosptal Virgen Macarena",{"type":57,"coordinates":70},[59,60],{"lat":60,"lon":59},[73],{"name":74,"role":43,"phone":75,"phoneExt":13,"email":76},"Frederico Arguelles Arias, MD","+34 955 00 80 00","farguelles1@us.es",{"type":78,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[80,83,85],{"name":81,"class":82},"University Hospital of Nuestra Señora de Valve","UNKNOWN",{"name":84,"class":82},"University Hospital of Virgen del Rocio",{"name":86,"class":82},"University Hospital of Virgen Macarena","100654022","artificial-intelligence-for-outcomes-research-in-crohns-disease-digital-pathology-assessment-of-fibrosis-and-association-with-patient-history-and-clinical-outcomes-100654022",false,"NCT07795476","Artificial Intelligence For Outcomes Research in Crohn's Disease: Digital Pathology Assessment of Fibrosis and Association With Patient History and Clinical Outcomes","AIFOR-CD","Inclusion Criteria:\n\n* Adult pts (\\>=18 years old) diagnosed with Crohn's disease based on Investigator's assessment.\n* Ileal biopsy with fibrosis Masson's Trichome staining available for digitization or already digitized at 40X ( or \\~0.25micron per pixel)\n* 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.\n* Minimum information available for each patient (see Appendix 2, table 1)\n\nExclusion Criteria:\n\n* History of gastrointestinal endoscopic interventions and\u002For surgery for Crohn's disease management such as endoscopic balloon dilation, strictureplasty, stricturectomy or bowel resection prior to the index biopsy.\n* History of gastrointestinal surgery for any indication","ALL","18 Years","80 Years",{"count":98,"type":99},100,"ESTIMATED","OBSERVATIONAL","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.\n\nThe main questions the study aims to answer are:\n\nDoes the FibroNest Phenotypic Fibrosis Composite Score \\[Ph-FCS(Muc)\\], measured from routinely collected ileal biopsies, reflect the severity of fibrosis assessed by a pathologist?\n\n* Is Ph-FCS(Muc) associated with Crohn's disease characteristics and history?\n* Can Ph-FCS(Muc) help predict whether a patient will subsequently require a first ileal surgical resection for fibrostenotic Crohn's disease?\n\nResearchers 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.",[103,104,105],"Crohn Disease","Fibrostenotic Crohn's Disease","CD - Crohn's Disease",[107,108,109],"Digital Pathology","Fibrosis","Artificial Intelligence","NOT_YET_RECRUITING","2026-09-28",{"date":113,"type":114},"2026-10-01","ACTUAL",{"date":116,"type":99},"2026-11-01",{"date":118,"type":99},"2027-05-15",{"name":5,"class":6},2]