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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03448822
Other study ID # M18TGC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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