Personalized Approach to Celiac Disease Diagnosis

Sponsor
The Cleveland Clinic
Study ID
NCT07701655
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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: Can a blood test and symptom information separate patients into 3 groups of low, intermediate, and high risk for celiac disease? Participants 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. The 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.

Key Dates

First listed
Jul 14, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2030
Completion
Apr 30, 2031

Study Design

Enrollment
15,500 participants (estimated)

Arms

  • Arm: Aim 1 Retrospective Cohort
    11300 patients evaluated for celiac disease from 1/1/2005-12/31/2021 from various sites, as well as 4000 internal patients evaluated from 1/1/2022-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.
  • Arm: 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
  • Arm: Aim 3 Survey Cohort
    100 patients will be asked to complete online surveys and consent to have their data input in the AI model.

Primary Outcome Measure

Aim 1 Prediction Model [ Time Frame: 1 year ]

Central Contacts

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