C61
Conditions
Interventions
Group 1: In total, 60 lymph node samples derived from 30 positive and 30 negative nodes will be analysed by immunohistochemical staining (AE1/AE3) as well as by the OSNA assay and RT-PCR for CK19.
Sponsors
Sysmex Europe GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Prostate cancer patients treated at Universitätsklinik für Urologie, Klinikum Oldenburg scheduled for radical prostatectomy and lymphadenectomy who gave their written consent to participate to the study.
Exclusion criteria
Exclusion criteria: • Patients who are affected by other metastatic cancer • Patients who were affected in the past by other malignancies • Patients who withdrew their consent to participate to the study or did not gave their consent to participate to study • Patients who underwent chemo- or radio-therapy before surgery • Patients judged to be incapable of participating in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study aims to assess the scientific validity of the method One Step Nucleic Acid Amplification (OSNA) in confirming the utility of cytokeratin 19 (CK19) messenger RNA (mRNA) for detecting metastasis in LN of prostate cancer. The scientific validity of the OSNA method will be determined by assessment of the marker CK19 mRNA expression levels and the cut-offs for metastasis detection. | — |
Countries
Germany
Contacts
Public ContactAlexander Winter
Universitätsklinik für Urologie, Klinikum Oldenburg AöR, Carl von Ossietzky Universität Oldenburg
Outcome results
None listed