MicroRNA-371 as Markers for Disease Activity and as a Tool to Monitor the Effect of Chemotherapy and Early Detection of Recurrence in Patients With Testicular Germ Cell Tumours
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 6
- 主要终点
- miR371 as a biomarker in testicular germ cell cancer during chemotherapy treatment
研究概览
简要总结
The main objective of this study is establish the performance of miR371 in management of testicular cancer
详细描述
The main objective of the study is to asses the sensitivity and specificity of microRNA-371a-5p (miR371) in detection of viable testicular germ tumour cells. To assess the utility of miR371 at orchiectomy, during treatment and surveillance and in early detection of recurrence.
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 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected testicular cancer, referred to orchiectomy.
- •Patients diagnosed with testicular germ cell cancer.
- •Age 18-70 years of age.
- •Must be able receive information and to consent.
排除标准
- •Other prior or concomitant malignancy (other than testicular cancer).
- •Other diseases or conditions that hinder the ability to receive information and to participate in follow-up procedures.
结局指标
主要结局
miR371 as a biomarker in testicular germ cell cancer during chemotherapy treatment
时间窗: 5 years
To estimate the performance of miR371 in monitoring of treatment efficiency (chemotherapy)
miR371 as a biomarker in testicular germ cell cancer and detection of recurrence
时间窗: 5 years
To estimate the performance of miR371 in (early) detection of recurrence
miR371 as a biomarker in testicular germ cell cancer at orchiectomy
时间窗: 5 years
To estimate the sensitivity and specificity of miR371 in identifying viable tumour cells at diagnosis
miR371 as a biomarker in testicular germ cell cancer at RPLND
时间窗: 5 years
To estimate the sensitivity and specificity of miR371 in identifying viable tumour cells at RPLND
次要结局
未报告次要终点