Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour (SENATOR)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Joost Blok, MD
- Phone Number: 0031 20 5129111
- Email: j.blok@nki.nl
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
sentinel node procedure
a robot-assisted laparoscopic sentinel node procedure.
|
a robot-assisted laparoscopic sentinel node procedure to detect occult lymph node metastasis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
identify patients witha low risk of cancer recurrenceincluded in current active surveillance protocols.
Time Frame: 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
|
surgery 1 day, follow up 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Simon Horenblas, MD, PhD, NKI-AVL
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M18TGC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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