Sequelae of Treatment in Survivors of Testicular Cancer Creation of a Non-exposed Comparison Group for the Platinum Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Proportion of patients with ototoxicity
研究概览
简要总结
The patients enrolled on this new study will serve as an appropriate comparison group consisting of patients with the diagnosis of germ cell testicular cancer who were cured with surgical resection and did not receive cisplatin-based chemotherapy with a group of patients from another study who did receive cisplatin-based chemotherapy.
详细描述
Primary Objective
To compare the prevalence of ototoxicity and neurotoxicity in GCT cancer survivors who only had surgery to a similar population from The Platinum Study (RSRB45410/1305011509) who received cisplatin-based combination chemotherapy.
Secondary Objective
To compare the prevalence of obesity, hypertension, and use of antidepressants/anxiolytics in GCT cancer survivors who only had surgery to a similar population from The Platinum Study who received cisplatin-based combination chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis or confirmation of diagnosis of a histologically or serologically confirmed testicular germ cell tumor (GCT) or GCT at another anatomic location
- •Age at GCT diagnosis: 55 years of age or younger
- •Males, 18 years of age or older at time of study consent
- •Subject is able to provide consent
- •Subject is able to speak and read English
- •Treatment consisted of surgery only (i.e., orchiectomy and/or retroperitoneal lymph node dissection [RPLND]) for either initial testicular germ cell tumor (GCT) or subsequent testicular cancer
- •Subject completed surgery > 1 year ago
- •Subject is currently undergoing active follow-up at IU
- •Subject did not require any subsequent chemotherapy, salvage chemotherapy treatment or bone marrow transplant.
- •Subject had no prior chemotherapy of any kind
排除标准
- •Patients with prior chemotherapy (whether for GCT or any other cancer)
结局指标
主要结局
Proportion of patients with ototoxicity
时间窗: 1 year after surgery
The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study.
Proportion of patients with neurotoxicity
时间窗: 1 year after surgery
The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study.
次要结局
- Proportion of patients with obesity(1 year after surgery)
- Proportion of patients with hypertension(1 year after surgery)
- Proportion of patients who use antidepressants/anxiolytics(1 year after surgery)
研究者
Lawrence Einhorn
Distinguished Professor of Medicine
Indiana University School of Medicine