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Blood test plus symptom check may spare thousands from celiac biopsy

NCT ID NCT07701655

Diagnosis Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

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Approved
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When the status isn't known

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First seen Jul 14, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This study aims to see if a blood test for TTG-IgA antibodies combined with symptom information can accurately sort adults into low, intermediate, or high risk for celiac disease. Researchers will analyze data from 15,500 patients who already had both a blood test and a duodenal biopsy. If the model works, people at low risk could avoid further testing, those at high risk might skip biopsy, and only intermediate-risk patients would need the invasive procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could replace many invasive biopsies with a simple blood test and questionnaire, making celiac diagnosis faster and less uncomfortable.
What could go wrong
The model may not be accurate enough to safely skip biopsies in all cases, and results from this large observational study need validation before changing practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 15,500 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

celiac disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Celiac disease

How to take part

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  1. The official record

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