Phase II Study of Effectiveness of Using Low-dose CT in Patient Undergoing Surveillance for Clinical Stage I Testicular Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Difference in size of the retroperitoneal lymph node mass
研究概览
简要总结
Patients with primary germ cell cancer of the testicles confined to the testis can avoid adjuvant treatment by entering a surveillance protocol. In the surveillance protocol, patients are followed for up to ten years with serial computed tomography scans to detect recurrence. Multiple CT scans expose patients to a significant amount of radiation, which may be associated with an increased risk of secondary malignancies. This study hypothesizes that low dose CT scans are as effective as standard dose CT scans in detecting disease recurrence in this setting and will significantly reduce radiation exposure in this group of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed testicular germ cell testicular cancer (GCT) with no clinical or tumour marker evidence of metastases
- •Stage I disease according to UICC stage groupings and currently on surveillance (in Year 1 of non-seminoma surveillance or year 1 or 2 of seminoma surveillance)
- •ECOG performance status 0 or 1
- •Stage I disease according to UICC stage Groupings
- •Initial Low dose CT considered by study radiologist to be of sufficient quality to allow surveillance using LDCT protocol
排除标准
- •any medical conditions that render the patient ineligible to undergo the protocol or procedure
研究组 & 干预措施
Patients with testicular germ cell cancer
Patients with testicular germ cell cancer who have either been newly diagnosed, or have stage I cancer already on surveillance program will undergo conventional and low dose CT. Based on the imaging, they may undergo a surveillance program using low-dose CT.
干预措施: Low-dose computed tomography (LDCT) (Diagnostic Test)
结局指标
主要结局
Difference in size of the retroperitoneal lymph node mass
时间窗: 9 years
The difference in size of lymph node mass at the time of relapse between low dose CT and conventional CT. This is to evaluate the effectiveness of using low-dose CT in patients undergoing surveillance.
次要结局
- Amount of false positive rate of LDCTs(6 years)
- Amount of prospective identification of first modality to detect relapse(6 years)
- Amount of prospective documentation of treatment for testicular germ cell cancer relapse(6 Years)
- Proportion of disease-free survival(6 years)
- Time on surveillance(6 years)
- Proportion of patients who have to discontinue LDCT surveillance(6 years)
- Proportion of patients unsuitable for LDCT surveillance(6 years)
- Proportion of overall survival(6 years)