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临床试验/NCT01753479
NCT01753479已完成不适用

Duodenal Spectroscopy Study for Cancer Diagnosis

Olympus Corporation8 个研究点 分布在 3 个国家目标入组 445 人开始时间: 2013年1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
445
试验地点
8
主要终点
The spectral data of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort

研究概览

简要总结

Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to adenocarcinoma patients.

详细描述

Pancreatic cancer (PC) is the most lethal of all major cancers with a five year survival rate of 5 %. While stage I and II tumors leads to an improvement in survival, almost all PCs are currently diagnosed at more advanced non-resectable stages since minimally invasive technique which is capable of screening early-stage PC does not exist. Serum CA19-9 is not recommended as a screening technique because of its low sensitivity and specificity. Imaging modalities such as MRI, CT, EUS and ERCP are more accurate but are not appropriate screening tools due to their high cost, discomfort and complications. Therefore, there is a strong demand for a screening tool with high sensitivity and specificity which is highly acceptable for the patient. The investigators would like to look at the spectroscopy technique for pancreatic cancer diagnosis via an upper endoscopy. A definite diagnosis of the patient is made with histology, cytology or imaging diagnosis. Therefore this study can be positioned as a feasibility study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Common inclusion criterion
  • Age is 18 years or older.
  • Informed consent was obtained.
  • Inclusion criterion for normal cohort
  • An upper GI endoscopy is scheduled to check upper abdominal symptoms.
  • No findings of pancreatic disorder as documented by CT or MRI or EUS
  • Inclusion criterion for PC suspicious cohort * A EUS or ERCP is scheduled to suspected pancreatic disorder.

排除标准

  • Common exclusion criterion
  • Severe cardiac disease
  • Severe respiratory disease
  • Bleeding disorders
  • Pregnancy

结局指标

主要结局

The spectral data of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort

时间窗: 1 year

To clarify that there is the statistically-significant difference between two cohorts.

次要结局

  • The sensitivity and specificity to detect UICC stage II pancreatic ductal adenocarcinoma among all participants.(1 year)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (8)

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