A Prospective Observational Cohort Study to Evaluate miRNA371 and Outcomes in Patients With Newly Diagnosed Germ Cell Tumor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Misure of the level of miRNA37 in plasma samples
研究概览
简要总结
This is a observational study aimed at evaluating miRNA 371a-3p (miRNA 371) as a specific marker for presence or absence of clinically detectable viable germ cell malignancy.
详细描述
This is a observational cohort study to evaluate miRNA 371 in male patients with history of germ cell tumor or newly diagnosed germ cell tumor.
Patients with newly diagnosed testicular germ cell cancers will be stratified in:
- Low risk of relapse (5-25% chance of recurrence with active germ cell malignancy). Patients with low risk designation will be assigned to a low intensity schedule of biospecimen collection and imaging requirements.
- Moderate risk of relapse (26-50% chance of recurrence). Patients with moderate risk designation will be assigned to a higher intensity schedule of biospecimen collection and imaging requirements including early repeat imaging and classic marker determination.
The BRIDGE study evaluate the plasma expression of miRNA 371 as biomarker of relapse and its ability to detect germ cell malignancy within each of the early stage testicular seminoma and nonseminoma groups.
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 must be ≥ 18 years of age.
- •Patients must have a new diagnosis of a germ cell tumor confirmed pathologically or serologically (diagnostic elevation of HCG/AFP). All primary sites, stages, histological subtypes of germ cell tumor are eligible. Metachronous second primary germ cell tumors are eligible.
- •If surgery is planned, male patients with Clinical Stage I testicular cancer must have orchiectomy completed within 42 days prior to registration.
- •Patients must have risk of relapse assessment determined by the local investigator prior to registration.
- •Patients must have initial imaging, laboratory and other clinical evaluations (see below) performed within 42 days prior to registration. Imaging reports, pathology reports and performance status will be collected.
- •Patients must have beta-human chorionic gonadotropin (beta-HCG), alpha- fetoprotein (AFP), and lactate dehydrogenase (LDH) assessments within 42 days prior to registration.
- •Patients must agree to provide informed consent and required blood specimens for the duration of the study.
排除标准
- •Patients with high risk of relapse or metastatic disease.
- •Patients with tumour assessments beyond the time frame required by the protocol.
- •Patients not complaint with the protocol schedule.
研究组 & 干预措施
Low risk of relapse
Low risk of relapse (5-25% chance of recurrence with active germ cell malignancy): patients with low risk designation will be assigned to a low intensity schedule of biospecimen collection and imaging requirements.
Moderate risk of relapse
Moderate risk of relapse (26-50% chance of recurrence): patients with moderate risk designation will be assigned to a higher intensity schedule of biospecimen collection and imaging requirements including early repeat imaging and classic marker determination.
结局指标
主要结局
Misure of the level of miRNA37 in plasma samples
时间窗: 48 months
The study will prospectively collect samples and performed scans to evaluate the ability of miRNA371 in detecting (or anticipate) disease progression.
Presence/absence of malignant cells detected by miRNA371
时间窗: 48 months
The study will validate the capacity of miRNA371 to assess the presence of viable malignant cells otherwise not visible with standard imaging.
次要结局
- Relapse on Surveillance(48 months)
- Relapse on Treatment(48 months)
- Relapse Free Survival(48 months)
- Overall Survival(48 months)