SENATOR: Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour
Study Details
Study Description
Brief Summary
Assessment of accuracy of sentinel node biopsy, defined as the false negative rate.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 occur in the lymph nodes as lymphogenic spread is the dominant route of dissemination. A sentinel node procedure, in which the sentinel lymph node is resected and pathologically examined, could be more reliable to identify patients who are likely to relapse.
Early identification of patients with micro-metastases in the sentinel node makes it possible to treat these patients at the earliest possible moment. Absence of metastases could lead in the future to a less intensive follow up protocol than the present one.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| sentinel node procedure a robot-assisted laparoscopic sentinel node procedure. |
Procedure: sentinel node procedure
a robot-assisted laparoscopic sentinel node procedure to detect occult lymph node metastasis
|
Outcome Measures
Primary Outcome Measures
- identify patients witha low risk of cancer recurrenceincluded in current active surveillance protocols. [surgery 1 day, follow up 5 years]
identify patients who have such a low risk of cancer recurrence that it is not necessary anymore to be included in current active surveillance protocols by removing the sentinal lymph node to check for occult metastasis
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The Netherlands Cancer Institute
Investigators
- Principal Investigator: Simon Horenblas, MD, PhD, NKI-AvL
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M18TGC