NCT03448822

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

August 22, 2018

Status Verified

January 1, 2018

Enrollment Period

1.6 years

First QC Date

January 30, 2018

Last Update Submit

August 21, 2018

Conditions

Testicular Germ Cell Tumor

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

sentinel node procedure

a robot-assisted laparoscopic sentinel node procedure.

Procedure: sentinel node procedure

Interventions

sentinel node procedurePROCEDURE

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

sentinel node procedure

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailstestical germ cell tumors
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients suspected of testicular germ cell tumour

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Testicular Germ Cell Tumor

Study Officials

  • Simon Horenblas, MD, PhD

    NKI-AvL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joost Blok, MD

CONTACT

0031 20 5129111j.blok@nki.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 28, 2018

Study Start

September 1, 2018

Primary Completion

April 1, 2020

Study Completion

April 1, 2026

Last Updated

August 22, 2018

Record last verified: 2018-01