Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour

Testicular Germ Cell Tumor Clinical Trial

— SENATOR  

Official title:

Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03448822
• Other study ID #: M18TGC
• Status: Not yet recruiting
• Start date: September 1, 2018
• Est. completion date: April 1, 2026

Study information

• Verified date: January 2018
• Source: The Netherlands Cancer Institute
• Contact: Joost Blok, MD
• Phone: 0031 20 5129111
• Email: j.blok[@]nki.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Procedure:
• sentinel node procedure
a robot-assisted laparoscopic sentinel node procedure to detect occult lymph node metastasis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	identify patients witha low risk of cancer recurrenceincluded in current active surveillance protocols.	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