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临床试验/NCT04636788
NCT04636788Unknown不适用

Diagnostic and Prognostic Values of EUS-FNA Specimens and Circulating Exosomal Small RNA in Patients With Pancreatic Cancer

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
102
试验地点
1
主要终点
senstivity

研究概览

简要总结

This study is for the verification of biomarkers for pancreatic cancer treatment using small RNA liquid biopsy, combined with EUS-FNA tissues.

详细描述

CA19-9 is the FDA approved biomarker for the diagnosis of pancreatic cancer. However, the specificity of CA19-9 to differentiate between pancreatic cancer, cholangiocarcinoma, or other pancreatic lesions is not satisfying enough.

Tumor cells secret abundant exosomes in the early stage. Circulating tumor cells are detected mainly in the advanced stage. Meanwhile, the role of non-coding RNA draws more and more attention in tumor area. Exosomes protect inside RNA from plasma RNase. Compared with long RNA, small RNA, including miRNA, snoRNA, tRNA, piRNA could exist more stably.

By means of next-generation sequencing, we look forward to finding new exosomal small RNA biomarkers.

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

  • pancreatic cancer patients
  • pancreatic lesions other than PAAD
  • chronic pancreatitis
  • cholangiocarcinoma

排除标准

  • diagnosed with other pathological types of cancer
  • treated with chemo/radio/surgery previously

结局指标

主要结局

senstivity

时间窗: up to 8 weeks

sensitivity of exo-sRNA

specificity

时间窗: up to 8 weeks

specificity of exo-sRNA to differentiate between PAAD and other benigh or malignant pancreatic occupying lesions

次要结局

  • survival time(up to 18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bin Cheng

Professor

Huazhong University of Science and Technology

研究点 (1)

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