Testicular Germ Cell Tumor
Conditions
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 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.
Interventions
PROCEDUREsentinel node procedure
a robot-assisted laparoscopic sentinel node procedure to detect occult lymph node metastasis
Sponsors
The Netherlands Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactJoost Blok, MD
Outcome results
None listed