Trials / Unknown
UnknownNCT03448822
Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 76 (estimated)
- Sponsor
- The Netherlands Cancer Institute · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | sentinel node procedure | a robot-assisted laparoscopic sentinel node procedure to detect occult lymph node metastasis |
Timeline
- Start date
- 2018-09-01
- Primary completion
- 2020-04-01
- Completion
- 2026-04-01
- First posted
- 2018-02-28
- Last updated
- 2018-08-22
Source: ClinicalTrials.gov record NCT03448822. Inclusion in this directory is not an endorsement.