Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 主要终点
- identify patients witha low risk of cancer recurrenceincluded in current active surveillance protocols.
研究概览
简要总结
Assessment of accuracy of sentinel node biopsy, defined as the false negative rate.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
identify patients witha low risk of cancer recurrenceincluded in current active surveillance protocols.
时间窗: 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
次要结局
未报告次要终点