Status:
NOT_YET_RECRUITING
Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour
Lead Sponsor:
The Netherlands Cancer Institute
Conditions:
Testicular Germ Cell Tumor
Eligibility:
MALE
18+ years
Brief Summary
Assessment of accuracy of sentinel node biopsy, defined as the false negative rate.
Detailed Description
Current practice in patients with Clinical Stage I (CS I) testicular germ cell tumour is active surveillance after orchiectomy, with relapses occurring in 15-20% of patients. The majority of relapses ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT03448822
Start Date
September 1 2018
End Date
April 1 2026
Last Update
August 22 2018
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