L40
Conditions
Interventions
Group 1: Formalin-fixed, paraffin-embedded (FFPE) skin samples, previously collected as part of routine diagnostics from patients diagnosed with psoriasis and eczema, will be used to perform the PsorX
Sponsors
Dermagnostix R&D GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: clinical diagnosis of sporiasis, eczema or diffenrential diagnosis of these diseases; skin biopsy was performed at time of diagnosis questioning; signed informed consent from patient
Exclusion criteria
Exclusion criteria: withdrawal of agreement material left of the tissue specimen block is insufficent to perform PsorX molecular classifier tissue block older than 10 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the sensitivity and specificity of the PsorX-LabDisk in relation to the reference diagnosis (final diagnosis). The final diagnosis is already established at the time of inclusion, while the PsorX-LabDisk result is obtained after the patient has been included and the bioprobe has been analyzed once using the PsorX-LabDisk. Definition of PsorX-LabDisk: A fully automated CE-IVD system based on RT-PCR for the molecular differentiation of psoriasis and eczema. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Determination of the sensitivity and specificity of the manual PsorX PCR workflow in relation to the reference (final diagnosis) - Determination of the sensitivity and specificity of the initial clinical diagnosis in relation to the reference (final diagnosis) - Determination of the sensitivity and specificity of the histopathological diagnosis in relation to the reference (final diagnosis) -Determination of the degree of agreement between four different dermatopathologists who have examined the same skin sample | — |
Countries
Germany
Contacts
Public ContactKristin Technau-Hafsi
Klinik für Dermatologie und Venerologie
Outcome results
None listed