K90.0
Conditions
Interventions
Group 1: Blood and tissue samples that are taken during routinely performed diagnostics to confirm or refute coeliac disease are examined.
The blood samples will be processed through specific antibod
Sponsors
Universität Leipzig
Institut für Laboratoriumsmedizin, Klinische Chemie und Molekulare Diagnostik
Eligibility
Sex/Gender
All
Age
5 Months to 17 Years
Inclusion criteria
Inclusion criteria: • Children and adolescents scheduled for duodenal biopsy as by standard clinical practice with primary aim to confirm (or refute) CD • Age 5 months to < 18 years • Written informed consent of the patient’s parents
Exclusion criteria
Exclusion criteria: • Former diagnosis of CD • GFD within the last 8 weeks • Immunosuppressive therapy within the last 8 weeks • Suspected lack of compliance • Participation in other interventional trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnosis based on the current standard will be compared to that of the proposed “diagnostic cascade” (which will not generally include a biopsy). Only the first assessment of the tissue sample will be utilized for the current standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The patients that would not have received a biopsy according to the new diagnostic method will be analysed as a sub-population. Of particular interest is whether or not the first evaluation of the tissue sample would have changed the diagnosis and, if so, if this change is in the right direction. 2.The diagnosis based on the current standard will be compared to that of the proposed “diagnostic cascade” (which will not generally include a biopsy). Only the first assessment of the tissue sample will be utilized for the current standard. The “true” diagnosis will be defined using the current standard, but employing the expert pathologists’ assessment of the tissue probe. 3.Correlations between antibody concentrations and Marsh staging will be analysed. 4. Die Korrelation zwischen der Konzentration verschiedener Antikörper wird bestimmt. 5.Those who go on a GFD (gluten-free diet) will be divided into three groups: those who are on the diet based only on the standard diagnosis, those on the diet based only on the new diagnostic method and those on the diet for whom both diagnoses agree. The recovery rates will be compared amongst these groups. 6.The “extended GAF3X peptides” test will be compared with antibody tests of IgG-anti-GAF3X. | — |
Countries
Austria, Germany, United Kingdom
Contacts
Public ContactJohannes Wolf
Universität LeipzigInstitut für Laboratoriumsmedizin, Klinische Chemie und Molekulare Diagnostik
Outcome results
None listed