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临床试验/NCT02703545
NCT02703545已完成不适用

International CAPS Registry: Operated Cases and Cases With Advanced Disease Among High-risk Individuals Participating in a Pancreatic Cancer Surveillance Program; a Case-control Study

Johns Hopkins University0 个研究点目标入组 58 人开始时间: 2014年2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
58
主要终点
Proportion of patients and resected lesions with pancreatic cancer in situ (high grade dysplasia) or invasive malignancy

研究概览

简要总结

Various centers around the world are currently investigating the feasibility and yield of surveillance for pancreatic cancer in high-risk individuals. Evidence is beginning to accumulate that surveillance may lead to the early detection of non-invasive precursor lesions and asymptomatic early stage cancer. Ultimately, the goal of surveillance is to reduce mortality in these high risk individuals, but before this can be confirmed many research questions need to be answered. While the numbers of high-risk individuals screened in each separate screening facility are likely too small to properly address many of these questions, pooling data comprises a sizable sample size providing unique research opportunities. The objective of this study is retrospectively review all cases of high-risk individuals participating in our pancreatic surveillance program in whom 1) a suspicious precursor lesions was detected for which a pancreatic resection was performed and 2) in whom an advanced malignant disease was diagnosed. The de-identified information will be entered into an international multicenter database registry.

详细描述

The study is a retrospective review of all cases of high-risk individuals participating in our pancreatic surveillance program in whom 1) a suspicious precursor lesions was detected for which a pancreatic resection was performed and 2) in whom an advanced malignant disease was diagnosed. The de-identified information will be entered into an international multicenter database registry.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Elevated pancreas cancer risk cohort with pancreas cancer or dysplastic pancreas changes

排除标准

  • 未提供

结局指标

主要结局

Proportion of patients and resected lesions with pancreatic cancer in situ (high grade dysplasia) or invasive malignancy

时间窗: 5 years

Prevalence of pancreatic neoplasia high risk patients who had surgery for detected lesions in screening programs

次要结局

  • Incidence of pancreatic in-situ and invasive malignancy after baseline screening(5 years)
  • Calculate survival time from point of diagnosis and treatment(5 years)
  • Calculate all-cause and disease specific mortality(5 years)
  • Indications for pancreas surgery(5 years)
  • Proportion of specific types of pancreatic neoplasms by lesion type(5 years)

研究者

申办方类型
Other
责任方
Sponsor

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