Coeliac DiseaseNCT07364461
Diagnostic Accuracy of IgA Anti-transglutaminase Antibodies Measured by CLIA for Predicting Villous Atrophy in Coeliac Disease
An observational study of Coeliac Disease, run by Hospital Mutua de Terrassa at 1 site in Spain.
Trial summary
Celiac disease (CD) is an autoimmune disorder in which ingestion of gluten leads to immune-mediated damage of the small intestine. Diagnosis has traditionally required histological confirmation of duodenal villous atrophy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coeliac Disease
- How many people
- 765 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Having undergone duodenal biopsy and a complete CD diagnostic work-up
- Eating a gluten-containing diet
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Celiac disease (CD) is an autoimmune disorder in which ingestion of gluten leads to immune-mediated damage of the small intestine. Diagnosis has traditionally required histological confirmation of duodenal villous atrophy.
Since 2012, European guidelines have allowed a biopsy-free diagnosis in paediatric patients with IgA anti-tissue transglutaminase 2 antibodies (TGA) levels greater than 10 times the upper limit of normal (>10 × ULN). In 2025, the diagnostic guidelines for adult CD included the possibility of biopsy-free diagnosis in patients younger than 45 years presenting TGA >10 × ULN, confirmed in a second serum sample. In both paediatric and adult guidelines, the supporting evidence was based almost exclusively on enzyme immunoassays (EIA) using chromogenic substrates such as ELISA or fluorogenic substrates such as FEIA.
Read more
In recent years, chemiluminescence immunoassays (CLIA) have largely replaced EIA in routine clinical practice. However, the optimal threshold for CD screening and for biopsy-free diagnosis using CLIA remains unclear, and the few available studies suggest values substantially higher than those established for EIA. Differences in analytical performance, wide variability in cut-off values, potential sex differences and limited real-world data raise concerns about the direct application of the >10 × ULN criterion to CLIA assays.
The primary aim of this study is to evaluate, in a community setting, the performance of CLIA-based TGA measurement to establish a threshold with high specificity and positive predictive value for duodenal villous atrophy (Marsh 2-3) suitable for biopsy-free CD diagnosis and to evaluate potential age and sex-related differences. The secondary aims are: 1) to determine the optimal cut-off for CD with duodenal atrophy screening; 2) to assess the accuracy of the manufacturer recommended cut-off.
- Conditions
- Coeliac Disease
- Keywords
- biopsy-free diagnosis, chemiluminescence immunoassays (CLIA), IgA anti-tissue transglutaminase 2 antibodies (TGA)
- 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 |
|---|---|---|
| CD patients | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal cut-off value of TGA levels measured by CLIA for biopsy-free CD diagnosis
The optimal TGA cut-off value for CD diagnosis with duodenal atrophy will be determined using the cost function minimization method to achieve positive predictive values and specificities of over 95%
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Jan 2020
- Primary completion31 Aug 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coeliac DiseaseStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 765 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364461
- Sponsor's protocol ID
- P/23-168
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of IgA Anti-transglutaminase Antibodies Measured by CLIA for Predicting Villous Atrophy in Coeliac Disease
- ClinicalTrials.gov ID
- NCT07364461
- Acronym / sponsor ID
- P/23-168
- Conditions
- Coeliac Disease
- Keywords
- biopsy-free diagnosis, chemiluminescence immunoassays (CLIA), IgA anti-tissue transglutaminase 2 antibodies (TGA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 765 participants (actual)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 23 Jan 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.
Celiac disease (CD) is an autoimmune disorder in which ingestion of gluten leads to immune-mediated damage of the small intestine. Diagnosis has traditionally required histological confirmation of duodenal villous atrophy.
Since 2012, European guidelines have allowed a biopsy-free diagnosis in paediatric patients with IgA anti-tissue transglutaminase 2 antibodies (TGA) levels greater than 10 times the upper limit of normal (>10 × ULN). In 2025, the diagnostic guidelines for adult CD included the possibility of biopsy-free diagnosis in patients younger than 45 years presenting TGA >10 × ULN, confirmed in a second serum sample. In both paediatric and adult guidelines, the supporting evidence was based almost exclusively on enzyme immunoassays (EIA) using chromogenic substrates such as ELISA or fluorogenic substrates such as FEIA.
In recent years, chemiluminescence immunoassays (CLIA) have largely replaced EIA in routine clinical practice. However, the optimal threshold for CD screening and for biopsy-free diagnosis using CLIA remains unclear, and the few available studies suggest values substantially higher than those established for EIA. Differences in analytical performance, wide variability in cut-off values, potential sex differences and limited real-world data raise concerns about the direct application of the >10 × ULN criterion to CLIA assays.
The primary aim of this study is to evaluate, in a community setting, the performance of CLIA-based TGA measurement to establish a threshold with high specificity and positive predictive value for duodenal villous atrophy (Marsh 2-3) suitable for biopsy-free CD diagnosis and to evaluate potential age and sex-related differences. The secondary aims are: 1) to determine the optimal cut-off for CD with duodenal atrophy screening; 2) to assess the accuracy of the manufacturer recommended cut-off.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD patients | – | – |
| Control | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Having undergone duodenal biopsy and a complete CD diagnostic work-up
- Eating a gluten-containing diet
Key exclusion criteria (5 listed)
- 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
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
Optimal cut-off value of TGA levels measured by CLIA for biopsy-free CD diagnosis
Time frame: Baseline
The optimal TGA cut-off value for CD diagnosis with duodenal atrophy will be determined using the cost function minimization method to achieve positive predictive values and specificities of over 95%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coeliac Disease, run by Hospital Mutua de Terrassa at 1 site in Spain.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal cut-off value of TGA levels measured by CLIA for biopsy-free CD diagnosis (time frame: Baseline). 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 23 Jan 2026.