Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour (SENATOR)

Netherlands Cancer Institute (NKI)

Status

Not yet enrolling

Conditions

Testicular Germ Cell Tumor

Treatments

Procedure: sentinel node procedure

Study type

Observational

Funder types

Other

Identifiers

NCT03448822

M18TGC

Details and patient eligibility

About

Assessment of accuracy of sentinel node biopsy, defined as the false negative rate.

Full 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.

Enrollment

76 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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