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Intestinal Celiac Disease (CD)-antibodies have been described as the best marker to reveal progression toward villous atrophy and could become the diagnostic marker to make prompt diagnosis in the wide clinical spectrum of CD reducing the delay in diagnosis and treatment. The introduction of either anti-endomysial antibodies (EMA) assay or rapid anti-Transglutaminase 2 (TG2) test on supernatant of mechanically lysed biopsy samples in the clinical practice would improve the diagnosis of CD, especially in clinically challenging scenarios. The availability of an accurate test for identifying intestinal CD-antibodies that do not need the culture of intestinal biopsy is less expensive, less time consuming and easier to perform would facilitate the implementation of such technology outside research laboratories, and enable the diagnosis of CD at the end of Gastrointestinal Endoscopy (GIE).
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of EMA assay detected on supernatant of mechanically lysed intestinal biopsy specimens | Sensitivity and specificity of EMA assay detected on mechanically lysed intestinal biopsies compared to the reference standard (serology + histopathology) | At the time of endoscopic examination |
| Diagnostic accuracy of rapid anti-TG2 test detected on supernatant of mechanically lysed intestinal biopsy specimens | Sensitivity and specificity of rapid anti-TG2 test detected on mechanically lysed intestinal biopsies compared to the reference standard (serology + histopathology) | At the time of endoscopic examination |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance of EMA assay and rapid anti-TG2 test on supernatant of mechanically lysed intestinal biopsy specimens with Culture-EMA results | At the time of endoscopic examination |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects included in the study will be children and young adults, between 1 to 22 years of age, referred to the Gastroenterology Unit for elective GIE
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigina De Leo | Contact | +39.040.3785.472 | luigina.deleo@burlo.trieste.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Burlo Garofolo | Recruiting | Trieste | 34137 | Italy |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |