跳至主要内容
临床试验/NCT05604573
NCT05604573招募中不适用

DNA Mutation Detection in Circulating Tumor DNA and Tissue by Massive Multiplex Allele Discrimination Priming System(mmADPS) for Pancreatic Cancer

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年2月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
correlation of genetic mutation

研究概览

简要总结

Based on the cell free nucleic acid analysis information of blood samples and genetic mutation profile of EUS-FNB tissue from pancreatic cancer, the concordance between them is evaluated. And based on this information, biomarkers for diagnosis, treatment, and prognosis of pancreatic cancer are explored.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Patients diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins
  • Patients aged 18 or older who voluntarily agrees to participate in the study and is willing to understand and comply with the subsequent treatment procedures and sample collection schedule
  • Among patients diagnosed with benign pancreatic diseases (pancreatic cyst, chronic pancreatitis, etc.), patients who have need for histological examination as control group

排除标准

  • Where the subject himself/herself refuses to fill out the consent form or is unable to fill out the consent form
  • If a laboratory test is impossible due to a qualitative problem with the collected blood sample
  • Where the collected tissue does not contain tissue of the desired malignant or benign disease

结局指标

主要结局

correlation of genetic mutation

时间窗: the day of study enrollment (baseline)

concordance of genetic mutation between tissue and blood of treatment-naive status

detection sensitivity of genetic mutation by mmADPS

时间窗: the day of study enrollment (baseline)

detection sensitivity of genetic mutation by mmADPS

次要结局

  • correlation of genetic mutation and prognosis(through study completion, an average of 1 year)

研究者

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

Sang Hyub Lee

Professor

Seoul National University Hospital

研究点 (1)

Loading locations...

相似试验