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

August 21, 2018 updated by: The Netherlands Cancer Institute
Assessment of accuracy of sentinel node biopsy, defined as the false negative rate.

Study Overview

Status

Not yet recruiting

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

Observational

Enrollment (Anticipated)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Joost Blok, MD
  • Phone Number: 0031 20 5129111
  • Email: j.blok@nki.nl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Patients suspected of testicular germ cell tumour

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
sentinel node procedure
a robot-assisted laparoscopic sentinel node procedure.
Procedure: 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

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Simon Horenblas, MD, PhD, NKI-AVL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

April 1, 2026

Study Registration Dates

First Submitted

January 30, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

February 28, 2018

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

January 1, 2018

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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