No-biopsy Approach in Celiac Disease: Cut-off Points for IgA Anti-tissue Transglutaminase Assays
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational [Patient Registry] |
Eligible Ages | N/A and Over |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05983978 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Instituto de Investigación Hospital Universitario La Paz |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Marta Molero-Luis, Dr |
Principal Investigator Affiliation | Hospital Universitario La Paz |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | Spain |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Celiac Disease |
Contact a Trial Team
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