Celiac DiseaseNCT05983978
No-biopsy Approach in Celiac Disease: Cut-off Points for IgA Anti-tissue Transglutaminase Assays
An observational study of Celiac Disease, run by Instituto de Investigación Hospital Universitario La Paz at 6 sites in Spain.
Trial summary
The main objective of this multicenter and observational study is to define the optimal threshold of different commercially available IgA anti-transglutaminase (tTG-IgA) antibody assays for celiac disease diagnosis (CD) avoiding the need for an intestinal biopsy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Celiac Disease
- How many people
- 150 participants
- Where
- 6 sitesSpain
- Study dates
- 2 Jan 2023to 31 Mar 2026
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be consecutively recruited from the gastroenterology departments (either adult or pediatric) of the participating hospitals.
Who may be able to join
- Patients, on gluten-containing diet, with TGt-IgA antibodies > Upper Limit of Normal (ULN) and intestinal biopsy confirming celiac disease (CD).
- Patients with TCRγδ+ >10% combined with decrease NK-like intraepithelial lymphocytes in the intestinal epithelium.
- Paediatric patients who meet ESPGHAN criteria (TGt-IgA antibodies >10xULN) without duodenal biopsy performed.
Who cannot join
- Patients already diagnosed with CD.
- Patients who refused duodenal biopsy.
- Patients with primary or secondary immunodeficiencies.
- Patients with malignancy.
- Recruited patients whose remaining serum cannot be sent to the reference centre, whose biopsies are of poor quality or who nod not sign the informed consent from.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Concepción Núñez Pardo de Vera, Dr contact
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Hospital Sant Joan de Deu
Barcelona
Elisabet Poyatos
- Recruiting
Hospital Universitario Lucus Augusti
Lugo, Lugo
Julia María Cabo del Riego
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Marta Molero-Luis, Dr, marta.molero@salud.madrid.org
- Recruiting
Hospital Ramon y Cajal
Madrid
Garbiñe Roy Ariño
- Recruiting
Hospital Universitario Fundación Jimenez Diaz
Madrid
María José Martínez Becerra
- Recruiting
Hospital Mutua Terrassa
Terrassa, Barcelona
Albert Martin Cardona
About this study
Official title: No-biopsy Approach for the Diagnosis of Celiac Disease: Definition of Cut-off Points for Different IgA Anti-tissue Transglutaminase Assays
The main objective of this multicenter and observational study is to define the optimal threshold of different commercially available IgA anti-transglutaminase (tTG-IgA) antibody assays for celiac disease diagnosis (CD) avoiding the need for an intestinal biopsy.
The main questions to be answered are:
Read more
- Is the anti-tTG-IgA titer cut-off above 10 times the upper limit of normal (ULN) useful in all anti-tTG IgA assays?
- Is the diagnostic performance of the newly defined cut-offs of anti-tTG-IgA the same in all the evaluated assays?
- Is the dynamic of the anti-tTG-IgA levels after the introduction of the gluten-free diet (GFD) similar across the different assays included in the study?
This is a prospective multicenter study that will enroll pediatric and adult patients with new-onset CD during the years 2023 and 2024. Serum from these patients will be collected for the determination of anti-tTG-IgA according to the local methodology (participating hospital) and by the anti-tTG IgA assays most commonly used in our country, which will be centralized in the same reference center (Hospital Universitario La Paz).
- Conditions
- Celiac Disease
- Keywords
- anti-transglutaminase IgA, no-biopsy approach
- Medical subject headings
- Celiac Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-transglutaminase-IgA titer
To define the optimal threshold for anti tTG-IgA levels using different commercially available assays that provide a positive predictive value of 100%.
Measured: The tTG-IgA will be measured at the time of patient recruitment and at the first follow-up (3-6 months from the start of the gluten-free diet).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start2 Jan 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (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.
- 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
- 150 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Hospital Sant Joan de Deu, Hospital Universitario Ramon y Cajal, Hospital Universitario Lucus Augusti, Hospital Universitario Fundación Jiménez Díaz, Instituto de Investigación Sanitaria Hospital Clínico San Carlos
- Responsible party
- Principal investigator, Marta Molero, Instituto de Investigación Hospital Universitario La Paz
- Investigators
- Marta Molero-Luis, Dr, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983978
- Sponsor's protocol ID
- PI-5473
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2023
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No-biopsy Approach for the Diagnosis of Celiac Disease: Definition of Cut-off Points for Different IgA Anti-tissue Transglutaminase Assays
- ClinicalTrials.gov ID
- NCT05983978
- Acronym / sponsor ID
- PI-5473
- Conditions
- Celiac Disease
- Keywords
- anti-transglutaminase IgA, no-biopsy approach
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Hospital Sant Joan de Deu, Hospital Universitario Ramon y Cajal, Hospital Universitario Lucus Augusti, Hospital Universitario Fundación Jiménez Díaz, Instituto de Investigación Sanitaria Hospital Clínico San Carlos
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 9 Aug 2023 (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 main objective of this multicenter and observational study is to define the optimal threshold of different commercially available IgA anti-transglutaminase (tTG-IgA) antibody assays for celiac disease diagnosis (CD) avoiding the need for an intestinal biopsy.
The main questions to be answered are:
- Is the anti-tTG-IgA titer cut-off above 10 times the upper limit of normal (ULN) useful in all anti-tTG IgA assays?
- Is the diagnostic performance of the newly defined cut-offs of anti-tTG-IgA the same in all the evaluated assays?
- Is the dynamic of the anti-tTG-IgA levels after the introduction of the gluten-free diet (GFD) similar across the different assays included in the study?
This is a prospective multicenter study that will enroll pediatric and adult patients with new-onset CD during the years 2023 and 2024. Serum from these patients will be collected for the determination of anti-tTG-IgA according to the local methodology (participating hospital) and by the anti-tTG IgA assays most commonly used in our country, which will be centralized in the same reference center (Hospital Universitario La Paz).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be consecutively recruited from the gastroenterology departments (either adult or pediatric) of the participating hospitals.
Key inclusion criteria (3 listed)
- Patients, on gluten-containing diet, with TGt-IgA antibodies > Upper Limit of Normal (ULN) and intestinal biopsy confirming celiac disease (CD).
- Patients with TCRγδ+ >10% combined with decrease NK-like intraepithelial lymphocytes in the intestinal epithelium.
- Paediatric patients who meet ESPGHAN criteria (TGt-IgA antibodies >10xULN) without duodenal biopsy performed.
Key exclusion criteria (5 listed)
- Patients already diagnosed with CD.
- Patients who refused duodenal biopsy.
- Patients with primary or secondary immunodeficiencies.
- Patients with malignancy.
- Recruited patients whose remaining serum cannot be sent to the reference centre, whose biopsies are of poor quality or who nod not sign the informed consent from.
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
Anti-transglutaminase-IgA titer
Time frame: The tTG-IgA will be measured at the time of patient recruitment and at the first follow-up (3-6 months from the start of the gluten-free diet).
To define the optimal threshold for anti tTG-IgA levels using different commercially available assays that provide a positive predictive value of 100%.
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 6 Aug 2025.
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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.
Concepción Núñez Pardo de Vera, Dr contact
Marta Molero-Luis, Dr principal investigator
Hospital Universitario La Paz
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Instituto de Investigación Hospital Universitario La Paz at 6 sites 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 3 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: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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 Marta Molero-Luis, Dr (0034660065755, marta.molero@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-transglutaminase-IgA titer (time frame: The tTG-IgA will be measured at the time of patient recruitment and at the first follow-up (3-6 months from the start of the gluten-free diet).). 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 6 Aug 2025.