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

Recruiting

• Conditions: C67; C60; Malignant neoplasm of bladder; Malignant neoplasm of penis

• Registration Number: DRKS00025032
• Lead Sponsor: niversitätsklinik für Urologie, Klinikum Oldenburg, Fakultät für Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität Oldenburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 88

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

patients who are unable to consent

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the OSNA analysis compared to conventionel histopathology and immunohistochemistry

Secondary Outcome Measures

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