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临床试验/NCT06195904
NCT06195904尚未招募不适用

Genomic Profiling of Pancreatic Cystic Tumors

Samsung Medical Center2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
250
试验地点
2
主要终点
Genetic variants of pancreatic cysts associated with malignancy assessed by next-generation sequencing

研究概览

简要总结

This study aims to find out whether quantitative and qualitative analysis, including genetic mutation analysis, of samples obtained from patients with pancreatic cysts is associated with the risk of malignancy, and helpful in the differential diagnosis of mucinous and serous cysts. The study design is a single-arm prospective cohort observational study. Using blood, pancreatic cyst fluid, and pancreatic cyst tissue, genetic mutation analysis and measurement of various biomarkers are performed, and the relationship between these and malignancy or whether they are helpful in distinguishing mucinous and serous cysts is analyzed. The primary outcome is genetic variants of pancreatic cysts associated with malignancy. The secondary outcomes are factors including genetic variants that differentiate mucinous from serous cysts.

详细描述

Pancreatic cysts, especially mucinous cysts, are precancerous lesions that can cause pancreatic cancer, and follow-up surveillance is important. However, there is a lack of clear medical evidence for the proper method and timing of follow-up, so the current follow-up strategies rely heavily on the opinions of experts. Although mucinous pancreatic cyst is known as a precancerous lesion, the incidence of cancer is about 1-5%. Therefore, if the risk of malignant disease can be more accurately predicted in patients with pancreatic cysts, patients with a high risk of malignant disease can be more intensively monitored and improved survival rates can be expected through early detection of pancreatic cancer. In addition, unnecessary medical resource consumption can be reduced by increasing the follow-up interval of pancreatic cyst patients with low risk of malignancy or not following them at all. To this end, in addition to imaging characteristics of pancreatic cysts, which are currently suggested as risk factors for malignancy in most guidelines for pancreatic cysts, differential diagnosis of pancreatic cysts based on new biomarkers such as genetic mutations and malignant risk assessment are necessary. Therefore, in this study, the investigators comprehensively analyze the blood, pancreatic cyst fluid, and pancreatic cyst tissue of patients with pancreatic cysts to explore biomarkers including genetic mutations that are helpful in the differential diagnosis of pancreatic cyst and the diagnosis of malignant tumors.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pancreatic cyst patients undergoing cyst aspiration or biopsy or surgical resection
  • Patients who gave written informed consent

排除标准

  • Anyone who has not signed a written consent form.
  • Patients deemed unsuitable for research (severe infection, drug abuse, severe mental illness, etc.)

结局指标

主要结局

Genetic variants of pancreatic cysts associated with malignancy assessed by next-generation sequencing

时间窗: Through study completion, an average of 3 years

Genetic variants showing significant differences between pancreatic cysts with high-grade dysplasia or invasive cancer and the remaining pancreatic cysts, assessed through next-generation sequencing

次要结局

  • Genetic variants that differentiate mucinous from serous cysts assessed by next-generation sequencing(Through study completion, an average of 3 years)

研究者

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

JooKyung Park

Associate professor

Samsung Medical Center

研究点 (2)

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