Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour

• Conditions: testicular germ cell tumour; testicular cancer; 10038597; 10025309

• Registration Number: NL-OMON46792
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 87

Inclusion Criteria

Patients suspected of testicular germ cell tumour, based on physical examination, ultrasound imaging, and tumour markers
Patients 18 years and older
No evidence of metastases on first staging (thoraco-abdominopelvic CT)
Written and signed informed consent

Exclusion Criteria

Patients with evidence of metastases at first staging
Patients with a second primary tumour
Patients with recent (< 6 months before diagnosis) surgical treatment to the external genitals or recent surgical intervention in the inguinal or retroperitoneal regions
Patients with previous abdominal surgery, necessitating open surgical approach for the sentinel node biopsy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint will be the false negative rate of sentinel node<br /><br>biopsy. False negative sentinel node rate will be calculated as follows:<br /><br>[number of patients with a false-negative sentinel node] / [total number of<br /><br>patients with tumor positive nodes]<br /><br>Patients with a false-negative sentinel node are defined as patients of whom<br /><br>the sentinel nodes were negative on histopathological examination, but who<br /><br>develop a recurrence during follow-up. Recurrence can be assessed by<br /><br>CT-scanning, thoracic X-ray, and serum tumour markers. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Sensitivity and specificity of the sentinel node approach, recurrence rate,<br /><br>cancer specific and overall survival, percentage of occult lymph node<br /><br>metastases, extra operating time, number of adverse events, and morbidity.</p><br>