Validation of a New Innovative Method for Specific Marker Detection in Celiac Disease
1 other identifier
observational
332
1 country
4
Brief Summary
Celiac disease (CD) is a common auto-immune disorder induced by gluten ingestion in genetically susceptible individuals (HLA-DQ2/DQ8). Gluten induces small-bowel villous atrophy and a specific immune response characterized by the production of CD-autoantibodies against transglutaminase 2 (anti-TG2) and endomysium (EMA). In symptomatic patients with positive-serum antibodies and villous atrophy, the diagnosis of CD is clearcut. However, 10-30% of patients evaluated for suspected CD show only mild histopathologic changes and fluctuating serologic markers, a condition identified as potential CD. In such cases the diagnosis may remain uncertain. CD-autoantibodies are produced by intestinal B-cells in the early phases of the disease, before their appearance in the serum and when the duodenal mucosa is still normal. Intestinal CD-antibodies (I-CD-abs) are a marker of CD, have a high sensitivity and specificity for CD and identify those patients with potential CD who are at risk of progression to villous atrophy. I-CD-abs can be detected by double immunofluorescence staining on frozen duodenal sections or by using an endomysial antibody assay in the culture medium of duodenal biopsies (EMAbiopsy). The diagnostic accuracy of these techniques is comparable as they both have high sensitivity and specificity. However, their implementation in clinical practice is limited because they require both experienced operators and well-equipped laboratories. There is an unmet need: the development of a new simple and effective diagnostic tool that any gastroenterology unit can use in routine diagnostics to ensure a prompt diagnosis in suspected CD patients, who may benefit from a therapy based on gluten-free diet, and to reduce both unnecessary medical investigations and diagnostic delays. In order to simplify and shorten times for the detection of these intestinal antibodies, the study aims to substitute the EMAbiopsy assay with a supernatant obtained quickly after mechanical lysis of fresh intestinal biopsy specimen. The obtained samples will be tested with rapid (about 15 minutes) immune-chromatographic anti-TG2 assay (Rapid Intestinal anti-TG2 Assay).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 4, 2023
CompletedFirst Submitted
Initial submission to the registry
March 15, 2024
CompletedFirst Posted
Study publicly available on registry
March 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedJune 13, 2024
June 1, 2024
1.6 years
March 15, 2024
June 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Sensitivity of the EMA-biopsy in comparison to the reference standard (serology + histology) for CD diagnosis
Through study completion, an average of 18 months
Specificity of the EMA-biopsy in comparison to the reference standard (serology + histology) for CD diagnosis
Through study completion, an average of 18 months
Sensitivity of the Rapid Intestinal anti-TG2 Assay in comparison to the reference standard (serology + histology) for CD diagnosis
Through study completion, an average of 18 months
Specificity of the Rapid Intestinal anti-TG2 Assay in comparison to the reference standard (serology + histology) for CD diagnosis
Through study completion, an average of 18 months
Study Arms (2)
Celiac Disease subjects
Controls subjects
Interventions
Evaluation of the reliability of the Rapid Intestinal anti-TG2 Assay for revealing anti-TG2 antibodies in duodenal biopsy specimens of patients suffering from CD, especially potential CD in which the diagnosis may be challenging. Intestinal anti-TG2 will be investigated also in patients suffering from other non-CD related gastrointestinal disorders. Sensitivity, specificity and likelihood ratios of the Rapid Intestinal anti-TG2 assay will be calculated and compared to the reference standard (serology + histopathology) of CD diagnosis.
Eligibility Criteria
Children (aged between 2 and 17 years) referred to the Gastroenterology Units for elective gastro-intestinal endoscopy.
You may qualify if:
- \- Patients undergoing an elective esophagogastroduodenoscopy (EGD) for suspected Celiac Disease (CD), eosinophilic esophagitis, autoimmune enteropathy, inflammatory bowel disease, gastritis, gastric or duodenal ulcer, gastroesophageal reflux disease.
You may not qualify if:
- Bleeding disorders
- Patients fulfilling the new European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) guidelines for diagnosing CD (version 2020) for a serology-based CD diagnosis
- Subjects in whom intestinal biopsies are not indicated as part of the diagnostic process
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Azienda Ospedaliera Universitaria Federico II
Napoli, Italy
Consorzio per Valutazioni Biologiche e Faramacologiche
Pavia, Italy
Azienda ULSS2 Marca Trevigiana
Treviso, Italy
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, 34137, Italy
Biospecimen
Blood and biopsies samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2024
First Posted
March 22, 2024
Study Start
October 4, 2023
Primary Completion
May 1, 2025
Study Completion
May 1, 2025
Last Updated
June 13, 2024
Record last verified: 2024-06