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临床试验/NCT01610531
NCT01610531已完成不适用

COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 4,118 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,118
试验地点
1
主要终点
Prevalence ratios between those of the COPARIME cohort and those of the general population.

研究概览

简要总结

Melanoma is nowadays an important public health problem because its growing incidence. Mass screening for melanoma is not recommended worldwide because of its low cost-effectiveness. Nevertheless targeted screening for patients at high risk for melanoma is promoted. This study is designed to assess the effectiveness and the acceptability of a melanoma targeted screening of melanoma, to estimate the risk function to develop a melanoma among patients at high risk according to the SAMScore and to estimate the ratio cost/ efficacy of the melanoma targeted screening. A cohort of 7700 patients is carried out in 2 departments covered by a registry of cancers. The recruitment had began in April 2011. Patients assessed at high risk according to the SAMScore were proposed a skin examination by their GP every year.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients more than 18 years old,
  • consulting their GP,
  • assessed at risk for melanoma according to the SAMScore
  • signed the consent.

排除标准

  • 未提供

结局指标

主要结局

Prevalence ratios between those of the COPARIME cohort and those of the general population.

时间窗: 5 years

Number of melanomas detected / Number of patients at high risk of melanoma defined by our selection tool.

次要结局

  • Probability to develop a melanoma at one year.(1 years)
  • Cost ratio for a screened melanoma.(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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