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Blood test may replace painful biopsy for celiac diagnosis

NCT ID NCT07364461

Diagnosis Sponsor: Hospital Mutua de Terrassa Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a newer type of blood test (CLIA) can reliably diagnose celiac disease without needing a biopsy of the small intestine. Researchers analyzed data from 765 adults who had both the blood test and a biopsy. The goal was to find the right cutoff value that would make the blood test accurate enough to confirm celiac disease on its own.

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 allow many adults with celiac disease to be diagnosed with a simple blood test instead of an invasive biopsy.
What could go wrong
This is a completed study analyzing existing data, not a new treatment trial. The findings may not apply to all populations or test brands.

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

765 people

The number who actually took part.

Started

Jan 2020

Finished

Dec 2025

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

Patients who had TGA measured by CLIA within the healthcare area served by the Catlab Clinical Analysis Laboratory, covering a population of 717.181 inhabitants as of 1 January 2024 (IDESCAT). This area includes primary care centres and three community hospitals: University Hospital Mútua Terrassa, University Hospital Consorci Sanitari de Terrassa and Consorci Corporació Sanitària Parc Taulí.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Inclusion Criteria: * Having undergone duodenal biopsy and a complete CD diagnostic work-up * Eating a gluten-containing diet Exclusion Criteria: * Having an unsuitable or non-performed duodenal biopsy * Incomplete clinical data * Inconclusive diagnostic findings * Previous diagnosis of CD with duodenal biopsy performed during gluten-free diet (GFD) * IgA deficiency

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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.

Coeliac disease

Contacts and locations

Locations

  • CatLab AIE

    Viladecavalls, Barcelona, 08232, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.