Celiac DiseasePACkeDNCT07701655
Personalized Approach to Celiac Disease Diagnosis
An observational study of Celiac Disease, run by The Cleveland Clinic.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Celiac Disease
- How many people
- 15,500 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to 30 Apr 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- Patients ≥18 who underwent duodenal biopsy during upper endoscopy and had a TTG-IgA antibody test 3 months before or 1 month after biopsy
- 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
- 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
Who cannot join
- 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:
- Children and vulnerable populations (e.g. pregnant women or prisoners)
- For Aim 3:
- Children and vulnerable populations (e.g. pregnant women or prisoners)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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?
Read more
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.
Read the 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.
- Conditions
- Celiac Disease
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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 | |
| Aim 3 Survey Cohort | 100 patients will be asked to complete online surveys and consent to have their data input in the AI model. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
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.
Measured: Years 2-3
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.
Measured: Years 4-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completion30 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire Jansson-Knodell, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701655
- Sponsor's protocol ID
- 26-327
- Other IDs
- 1K23DK147757-01
- Acronym
- PACkeD
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Approach to Celiac Disease Diagnosis
- ClinicalTrials.gov ID
- NCT07701655
- Acronym / sponsor ID
- PACkeD / 26-327
- Conditions
- Celiac Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15,500 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- 30 Apr 2031 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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 |
| Aim 3 Survey Cohort | – | –100 patients will be asked to complete online surveys and consent to have their data input in the AI model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- Patients ≥18 who underwent duodenal biopsy during upper endoscopy and had a TTG-IgA antibody test 3 months before or 1 month after biopsy
- 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
- 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
Key exclusion criteria (8 listed)
- 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
- Children and vulnerable populations (e.g. pregnant women or prisoners)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aim 1 Prediction Model
Time frame: 1 year
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.
Aim 2 Interview Transcript Coding
Time frame: Years 2-3
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.
Aim 3 Model Performance and Patient Preferences
Time frame: Years 4-5
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by The Cleveland Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire Jansson-Knodell, MD (2164446354, JANSSOC@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1 Prediction Model (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.