NCT00420862终止3 期
The DANTE Trial. A Randomized Study on Lung Cancer Screening With Low-Dose Spiral Computed Tomography
Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2001年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 2,400
- 试验地点
- 1
研究概览
简要总结
High survival rates have been reported for screen-detected Stage I lung cancer patients, but there are concerns about the potential biases of uncontrolled studies. DANTE is a prospective randomized controlled trial exploring the effects of screening with LDCT on lung-cancer-specific mortality, and on the prevalence and incidence rates of lung cancer, stage distribution and resectability rates in a selected high-risk population. The prevalence of a set of biomarkers in sputum and blood samples is also being determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 74 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 60-74 years
- •smokers of more than 20 cigarettes/day for at least 20 years (actual smokers or ex-smokers from no more than 10 years)
排除标准
- •severe cardiopathy
- •advanced BPCO with chronic hypoxaemia (rest SatO2 < 94%)
- •chronic severe renal insufficiency
- •hypertension not controlled with drugs
- •type 2 diabetes or other severe systemic disease
- •severe previous cerebrovascular lesions with permanent invalidity (not self-sufficient).
- •severe vascular lesions with repeated ictus, trophic lesions, or limb loss, if actual smoker
- •Dementia, psychosis, severe depression or maniac-depressive syndrome
- •actual or precedent neoplasia, excepted skin tumor not-melanoma or scaly cells laryngeal and buccal cavity tumor, N0, recovered from more than 10 years or other tumors recovered from more than 10 years
- •transplantation less than 5 years or with rejection episodes in the last 2 years
- •unable subjects
研究者
研究点 (1)
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