Validation of a New Innovative Method for Specific Marker Detection in Celiac Disease
NCT ID: NCT06324539
Last Updated: 2024-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
332 participants
OBSERVATIONAL
2023-10-04
2025-05-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Celiac Disease subjects
Diagnostic Test: Rapid Intestinal anti-TG2 Assay
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.
Controls subjects
Diagnostic Test: Rapid Intestinal anti-TG2 Assay
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.
Interventions
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Diagnostic Test: Rapid Intestinal anti-TG2 Assay
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.
Diagnostic Test: Rapid Intestinal anti-TG2 Assay
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
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Inclusion Criteria
Exclusion Criteria
* 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
2 Years
17 Years
ALL
No
Sponsors
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IRCCS Burlo Garofolo
OTHER
Responsible Party
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Locations
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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, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PNRR-POC-2022-12376280
Identifier Type: -
Identifier Source: org_study_id
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