Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour

Not yet recruiting

• Conditions: Testicular Germ Cell Tumor
• Interventions: Procedure: sentinel node procedure

• Registration Number: NCT03448822
• Lead Sponsor: The Netherlands Cancer Institute

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.

Study Timeline

• Status Verified: 2018-01
• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-02-28
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-22
• Study Start: 2018-09-01
• Primary Completion: 2020-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 76

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sentinel node procedure	sentinel node procedure	a robot-assisted laparoscopic sentinel node procedure.

Primary Outcome Measures

Name	Time	Method
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