跳至主要内容
临床试验/NCT04625556
NCT04625556招募中不适用

Development of Urologic Registry for Personalized Medicine in Patients With Urologic Malignant Diseases by Analyzing Microbiome

Yonsei University1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2022年12月19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
3,000
试验地点
1
主要终点
Correlation between plasma bacteria composition and prevalence of urological malignancies

研究概览

简要总结

Genitourinary malignancies such as prostate cancer, renal cell cancer, and bladder cancer in Korean population have been increased due to the aged population and the westernized lifestyles. With the advancement of technologies, studies have found that microbiome not only affects human physiological functions, such as metabolism, immunity, and haematopoiesis, but also plays a significant role in the development and progression of malignancies. However, the investigation of microbiome in urological malignances have been limited and few studies have been reported. Therefore, the investigator tried to evaluate the usefulness of microbiome in detection and monitoring of urological malignancies in Korean population. This study aims to use microbiome in tissue, plasma, stool and urine for the diagnosis, disease progression monitoring and therapeutic response evaluation. This study plan includes building big databases for microbiome of urological malignancies in Korean population.

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

入选标准

  • Patients diagnosed as urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer)
  • Patients who have undergone surgeries due to urological malignancies in Severance Hospital, Sinchon from 2020.10 and 2030.10
  • Those who agree to give permission to use their human source information
  • Those who agree with this study

排除标准

  • Those who do not agree with this study
  • Vulnerable participants who are likely to be vulnerable to coercion or undue influence or lack decision-making

结局指标

主要结局

Correlation between plasma bacteria composition and prevalence of urological malignancies

时间窗: within 2 weeks after the surgery

evaluate and compare the bacteria composition in plasma samples in urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) with healthy control group

Correlation between stool bacteria composition and prevalence of urological malignancies

时间窗: within 2 weeks after the surgery

evaluate and compare the bacteria composition in stool samples in urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) with healthy control group

Correlation between urine bacteria composition and prevalence of urological malignancies

时间窗: within 2 weeks after the surgery

evaluate and compare the bacteria composition in urine samples in urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) with healthy control group

Correlation between tissue bacteria composition and prevalence of urological malignancies

时间窗: within 2 weeks after the surgery

evaluate and compare the bacteria composition in tissue samples in urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) with healthy control group

次要结局

  • Correlation of bacteria composition and tumor response assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)(within 10 years after the surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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