Swiss Austrian German Testicular Cancer Cohort Study - SAG TCCS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6,900
- 试验地点
- 1
- 主要终点
- Mode of relapse detection
研究概览
简要总结
The majority of testicular cancer patients can be cured with cisplatin-based chemotherapy. Mortality has been reduced even more within the last 15 years due to the stringent application of standard chemotherapy followed by resection of residual disease. This is a positive development considering that testicular cancer usually affects young men. Active surveillance has become an acceptable and widely used strategy in stage I testicular cancer. Thus, it is important to follow these patients in a standardized way and to adhere to a rationale surveillance strategy. There is no international consensus regarding follow-up of testicular cancer patients. Stratification according to risks and patterns of relapse would allow to tailor follow-up schedules, aiming at early identification of relapse without causing unnecessary harm by using excessive radiation in these young long-term survivors. Follow-up procedures should not only aim at detecting relapse, but also long-term side effects from therapy, including hypogonadism, metabolic syndrome, cardiovascular disease and secondary malignancies. The Swiss Austrian German Testicular Cancer Cohort Study (SAG TCCS) will comprise consecutive newly diagnosed testicular cancer patients and is the first study to prospectively evaluate the initial indictor of relapse in testicular cancer patients, the frequency and pattern of relapse and document long-term toxicities of the treatment (cardiovascular, gonadal, hearing impairment, renal function and second malignancies) and psychosocial aspects. This cohort study will determine the relevance of each test performed routinely during follow-up. The collected data will have direct implications for the care of patients with testicular cancer and inform future adaptations of follow-up recommendations. The dataset will give information on baseline factors of testicular cancer patients patients, current treatment strategies in Switzerland, Austria and Germany, outcome and late sequelae.
详细描述
Objectives
Primary objective
The primary objective is to determine the diagnostic performance and the clinical impact of a variety of tests, including conventional radiographs, computer tomographies (CT), abdominal ultrasound, serum tumour markers (AFP, beta-HCG and LDH) and clinical signs and symptoms aimed at early detection of relapse after curative therapy with documented complete remission.
Secondary objectives
Diagnostic performance:
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
- •Written informed consent.
- •Histologically proven seminomas or non-seminoma.
- •Seminoma: complete remission (CR) or lymph nodes (LN) < 3cm or PET negative partial remission (PR) or non-seminoma: CR.
- •Completion of treatment within the last 6 months.
- •Patient able and willing to attend for regular surveillance.
排除标准
- •Co-existent malignancy within 5 years.
- •Inability for any reason to comply with the trial investigations or follow-up schedules.
结局指标
主要结局
Mode of relapse detection
时间窗: 8 years
Diagnostic performance and the clinical impact of a variety of tests, including conventional radiographs, computed tomographies (CT), abdominal ultrasound, serum tumour markers (AFP, beta-HCG and LDH) and clinical signs and symptoms aimed at early detection of relapse after curative therapy with documented complete remission.
次要结局
- Rate of false positive abnormalities on CT scan(8 years)
- Rate of false positive tumour marker elevations not due to seminomatous or non-seminomatous germ cell tumour relapses but due to other reasons(8 years)
- Rate of stage I seminoma and non-seminoma patients undergoing active surveillance.(8 years)
- Overview of treatment and follow-up strategies in germ cell cancer patients in Switzerland, Austria and Germany(8 years)
- Rate of relapses detected on chest x-ray in seminoma patients(8 years)
- Patient characteristics at baseline and at the time-point of relapse detection.(8 years)
- Rate of offspring spontaneously conceived after testicular cancer treatment.(8 years)
- Rate of intermediate and poor-prognosis disease at relapse.(8 years)
- Treatment sequelae following testicular cancer treatment in terms of organ function, cardiovascular risk factors, sexual health and socioeconomic aspects.(8 years)
研究者
Dr. med. Christian Rothermundt
PD Dr. med.
Cantonal Hospital of St. Gallen