Evaluation of One-step Nucleic Acid Amplification (OSNA) for the detection of lymph node metastases in bladder and penile carcinoma

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025032

Enrollment

Registered

2021-04-29

Start date

2021-05-24

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C67 C60

Interventions

Group 1: Patients with bladder cancer (= pT2 or pT1 G3 and suspected LN metastases in CT/MRT who also receive an extented lymphadenectomy besides cystectomy) or patients with penile cancer (= pT1 G2 w

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Bladder cancer: - patients with progressed bladder carcinoma = pT2 - patients with bladder carcinoma pT1 G3 and suspected LN metastases in CT/MRT - patients who also receive an extented lymphadenectomy besides cystectomy Penile cancer: - patients with penile carcinoma who are recommended an inguinal lymphadenectomy according to EAU guidelines (= pT1 G2)

Exclusion criteria

Exclusion criteria: patients who are unable to consent

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of the OSNA analysis compared to conventionel histopathology and immunohistochemistry	—

Secondary

Measure	Time frame
concordance and level of agreement (Cohen's kappa) between OSNA and histopathology taking account of the size of metastasis (micro-/macrometastasis)	—

Countries

Germany

Contacts

Public ContactAlexander Winter

Universitätsklinik für Urologie, Klinikum Oldenburg, Fakultät für Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität Oldenburg

winter.alexander@klinikum-oldenburg.de04414032302

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026