Personalized Approach to Celiac Disease Diagnosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Celiac Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
The specific aims of this study are to: 1) develop and validate a clinical prediction model for celiac disease probability (external validation will be performed by site and time), 2) evaluate the implementation potential of the model, and 3) pilot the model and determine its impact on patient experience.
Primary outcome measures
- Aim 1 Prediction Model [Time frame: 1 year]
- Aim 2 Interview Transcript Coding [Time frame: Years 2-3]
- Aim 3 Model Performance and Patient Preferences [Time frame: Years 4-5]
Eligibility criteria
For Aim 1:
Inclusion criteria
- Patients ≥18 who underwent duodenal biopsy during upper endoscopy and had a TTG-IgA antibody test 3 months before or 1 month after biopsy
Exclusion criteria
- Patients with a prior diagnosis of celiac disease undergoing biopsy and TTG-IgA antibody testing for follow-up care
- Children and vulnerable populations (e.g. pregnant women or prisoners)
- Patients with IgA deficiency
- Patients already following a gluten-free diet
For Aim 2:
Inclusion criteria
- Physicians (primary care or subspeciality) who test or evaluate patients for celiac disease
- Patients already diagnosed with celiac disease or undergoing evaluation for celiac disease
Exclusion criteria
\- Children and vulnerable populations (e.g. pregnant women or prisoners)
For Aim 3:
Inclusion criteria
- Patients ≥18 with a standard-of-care celiac disease evaluation (both TTG-IgA antibody and upper endoscopy with duodenal biopsy)
- Willing to participate and able to provide informed consent
Exclusion criteria
\- Children and vulnerable populations (e.g. pregnant women or prisoners)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07701655 · 26-327 · 1K23DK147757-01