Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour

Launched by THE NETHERLANDS CANCER INSTITUTE · Feb 27, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at a procedure called sentinel lymph node biopsy for men who may have a testicular germ cell tumor, which is a type of cancer that starts in the testicles. The main goal of the study is to see how accurate this biopsy is, specifically by measuring how often it wrongly indicates that there is no cancer when there actually is (this is known as the false negative rate).

To participate in this trial, you need to be a man aged 18 years or older who has been suspected of having this type of tumor based on certain tests, like physical exams and imaging. You must also have no signs that the cancer has spread to other parts of the body at the time of your first scans. Participants will be asked to provide written consent and will undergo the biopsy procedure to help researchers understand its effectiveness. It's important to note that people with evidence of cancer spread, certain other cancers, or recent surgeries in specific areas will not be eligible for this trial.

Gender

MALE

Eligibility criteria

• 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