Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour | NCT03448822

Studies
Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour

NCT03448822

Sponsor

The Netherlands Cancer Institute

Status

Unknown status

Last Update Posted

Aug 22, 2018Actual

Enrollment

76Estimated

Phase

Not provided

Conditions

Testicular Germ Cell Tumor

Interventions

sentinel node procedure

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2018Estimated

Primary Completion Date

Apr 1, 2020Estimated

Completion Date

Apr 1, 2026Estimated

First Submitted Date

Jan 30, 2018

First Submission Date that Met QC Criteria

Feb 27, 2018

First Posted Date

Feb 28, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2018

Last Update Posted Date

Aug 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

76Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sentinel node procedure		a robot-assisted laparoscopic sentinel node procedure.	Procedure: sentinel node procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sentinel node procedure	Procedure	a robot-assisted laparoscopic sentinel node procedure to detect occult lymph node metastasis	sentinel node procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

testical germ cell tumors

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients suspected of testicular germ cell tumour

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joost Blok, MD	Contact	0031 20 5129111		j.blok@nki.nl

Overall Officials

Name	Affiliation	Role
Simon Horenblas, MD, PhD	NKI-AvL	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C563236	Testicular Germ Cell Tumor

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided