[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645678":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":18,"locations":10,"responsibleParty":24,"collaborators":28,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":36,"acronym":37,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":10,"enrollmentInfo":41,"targetDuration":10,"studyType":44,"phases":10,"briefSummary":45,"conditions":46,"keywords":10,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":10},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Aim 1 Retrospective Cohort",null,"11300 patients evaluated for celiac disease from 1\u002F1\u002F2005-12\u002F31\u002F2021 from various sites, as well as 4000 internal patients evaluated from 1\u002F1\u002F2022-September 2025 will be used to validate the AI model. All 15300 patients are from a previously IRB approved study that had the goal of using for AI model validation.",{"label":13,"type":10,"description":14,"interventionNames":10},"Aim 2 Interview Cohort","30 patients with celiac disease will be recruited to participate in interviews regarding preferences in the diagnostic approach to celiac disease. Approximately 20 physicians (primary care, gastroenterology, and subspeciality physicians from Cleveland Clinic, identified based on their past one-year total number of patients diagnosed with celiac disease, selecting those in the top quartile of each specialty) will be interviewed regarding typical celiac diagnostic approach, concerns about use of a prediction model, etc. Finally, up to 5 physician-leaders (in Gastroenterology, including the Department Chair, General Gastroenterology Section Head, and members of the clinical practice committee) will be interviewed on perspectives on changing the clinical workflow, comfort with use of clinical prediction models for diagnosis, including liability, etc",{"label":16,"type":10,"description":17,"interventionNames":10},"Aim 3 Survey Cohort","100 patients will be asked to complete online surveys and consent to have their data input in the AI model.",[19],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Claire Jansson-Knodell, MD","CONTACT","2164446354","JANSSOC@ccf.org",{"type":25,"investigatorFullName":26,"investigatorTitle":27,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Claire Jansson-Knodell","Assistant Professor of Medicine",[29],{"name":30,"class":31},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100645678","personalized-approach-to-celiac-disease-diagnosis-100645678",false,"NCT07701655","Personalized Approach to Celiac Disease Diagnosis","PACkeD","For Aim 1:\n\nInclusion Criteria:\n\n* Patients ≥18 who underwent duodenal biopsy during upper endoscopy and had a TTG-IgA antibody test 3 months before or 1 month after biopsy\n\nExclusion Criteria:\n\n* Patients with a prior diagnosis of celiac disease undergoing biopsy and TTG-IgA antibody testing for follow-up care\n* Children and vulnerable populations (e.g. pregnant women or prisoners)\n* Patients with IgA deficiency\n* Patients already following a gluten-free diet\n\nFor Aim 2:\n\nInclusion Criteria:\n\n* Physicians (primary care or subspeciality) who test or evaluate patients for celiac disease\n* Patients already diagnosed with celiac disease or undergoing evaluation for celiac disease\n\nExclusion Criteria:\n\n\\- Children and vulnerable populations (e.g. pregnant women or prisoners)\n\nFor Aim 3:\n\nInclusion Criteria:\n\n* Patients ≥18 with a standard-of-care celiac disease evaluation (both TTG-IgA antibody and upper endoscopy with duodenal biopsy)\n* Willing to participate and able to provide informed consent\n\nExclusion Criteria:\n\n\\- Children and vulnerable populations (e.g. pregnant women or prisoners)","ALL","18 Years",{"count":42,"type":43},15500,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about an adult's chance of having celiac disease based on blood testing and symptoms. The main question it aims to answer is:\n\nCan a blood test and symptom information separate patients into 3 groups of low, intermediate, and high risk for celiac disease?\n\nParticipants already being evaluated for celiac disease as part of regular medical care will answer online survey questions about symptoms and have laboratory data collected from charts.\n\nThe investigators hypothesize that a clinical prediction model integrating clinical data with TTG-IgA antibody levels can accurately identify patients with celiac disease offering a personalized approach. The investigators anticipate this prediction model would classify patients into 3 risk groups for celiac disease: 1) Low likelihood (no further testing required), 2) Intermediate likelihood (biopsy required for confirmation), and 3) High likelihood (biopsy can be avoided based on the model's accuracy) thereby reserving endoscopy and biopsies for cases of intermediate probability to improve diagnosis, reduce invasive testing, increase patient focus, and decrease costs.",[47],"Celiac Disease","NOT_YET_RECRUITING","2026-07-17",{"date":51,"type":52},"2026-07-20","ACTUAL",{"date":54,"type":43},"2026-08",{"date":56,"type":43},"2031-04-30",{"name":5,"class":6}]