Personalized Approach to Celiac Disease Diagnosis
ConditionCeliac Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Cleveland Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥18 who underwent duodenal biopsy during upper endoscopy and had a TTG-IgA antibody test 3 months before or 1 month after biopsy
Disqualifiers
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
Trial population
The study population for Aim 1 is all adult patients ≥18 who underwent duodenal biopsy during upper endoscopy and had a TTG-IgA antibody test 3 months before or 1 month after biopsy. First pathology data will be reviewed to identify duodenal biopsies conducted during the study period then TTG-IgA antibody availability will be confirmed. The investigators aim to study incident cases. The study population is similar for Aim 3 - patients being evaluated for celiac disease. The study population for Aim 2 includes primary care, gastroenterology, and subspeciality physicians diagnosing celiac disease and patients with or being evaluated for celiac disease.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
15,500 Participants
are grouped into 3 trial groupsGroup A: Aim 1 Retrospective Cohort
Group B: Aim 2 Interview Cohort
Group C: Aim 3 Survey Cohort
Trial outcomes
Primary outcomes
1
Aim 1 Prediction Model
The primary outcome being predicted is biopsy-confirmed celiac disease, defined as villous atrophy on duodenal histopathology. A prediction model will be built and after final model construction, the investigators will report its performance using five established measures: sensitivity, specificity, positive predictive value, negative predictive value, and F-measure. A calibration plot will be produced to illustrate if the model's predicted probabilities of an outcome reflect the true outcome probability. The investigators will use the SHapley Additive exPlanation (SHAP) method to provide a list of all model features ranked according to relative importance.
Time frame
1 year2
Aim 2 Interview Transcript Coding
Interview transcripts will be uploaded into NVivo software, a qualitative data analysis tool that facilitates coding of source data and identification of similarities in coded concepts indicative of themes. A research assistant and the PI will independently inductively code interviews in NVivo. Data-driven codes will be combined with a priori codes corresponding to the PRISM domains to develop the study codebook and summarize themes. We will map these codes to the PRISM framework to understand how the intervention, recipients, implementation structure, and external environment interact to support implementation of a prediction model for celiac disease diagnosis.
Time frame
Years 2-33
Aim 3 Model Performance and Patient Preferences
For aim 3, the primary outcome of interest will be model accuracy reported as AUC, AUPRC, sensitivity, and specificity. We will describe patient-reported preferences for communication and display of the prediction model, as well as ranking of decisional attributes (e.g. discomfort, certainty in results). Best practices for survey reporting will be used.
Time frame
Years 4-5Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Cleveland Clinic
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: