Assessment of the Utility of CT Follow Up in the Long Term Follow Up of Patients With Metastatic Non Seminomatous Germ Cell Tumour (NSGCT)
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Rate of abnormalities due to nonseminomatous germ cell tumour (NSGCT) detected on initial CT-scan
研究概览
简要总结
RATIONALE: Learning about long-term effects in patients with testicular cancer may help doctors plan better treatment and follow-up care.
PURPOSE: This clinical trial is using CT scans to follow patients who have been treated for metastatic testicular cancer.
详细描述
OBJECTIVES:
- To assess the frequency of relapse or recurrent abnormalities detected by CT scan in patients on long-term follow-up for metastatic nonseminomatous germ cell tumour (NSGCT).
- To assess the utility of CT scan-assessment in these patients.
- To assess the prognostic factors predictive of late relapse in NSGCT.
OUTLINE: This is a multicenter study.
Patients are screened by CT scan of the chest, abdomen, and pelvis for detectable abnormalities or indications of late relapse. Scans are classified as positive or negative, according to standard CT criteria, by a radiologist with expertise in testicular cancer imaging. Patients with negative scans are followed yearly by clinical examination and tumor marker assessment, and every 5 years by CT imaging. Additional follow-up is performed at the discretion of the attending physician. Patients with positive scans undergo confirmation of relapse, whenever possible, by surgical excision or biopsy and treatment is initiated according to best clinical practice. If the follow-up scan is equivocal, patients are advised to have a follow-up scan of the affected region in 6 months.
研究设计
- 研究类型
- Observational
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Rate of abnormalities due to nonseminomatous germ cell tumour (NSGCT) detected on initial CT-scan
次要结局
- Rate of false positive abnormalities not due to NSGCT but due to benign process
- Rate of relapse following initial CT scan
- Number of abnormalities detected on second CT scan
