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临床试验/NCT00553371
NCT00553371Unknown不适用

Assessment of the Utility of CT Follow Up in the Long Term Follow Up of Patients With Metastatic Non Seminomatous Germ Cell Tumour (NSGCT)

Royal Marsden NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年4月最近更新:
适应症

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

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

研究者

申办方类型
Other

研究点 (1)

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