跳至主要内容
临床试验/NCT05725304
NCT05725304进行中(未招募)不适用

National Health Research Institutes,Taiwan

National Health Research Institutes, Taiwan1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
500
试验地点
1
主要终点
Development of an integrated database of genetic background

研究概览

简要总结

This project is a nationwide precision medicine program for urothelial carcinoma and renal cell carcinoma.

详细描述

This project providing free and immediate next-generation gene sequencing testing for patients with urothelial and renal cell carcinomas that have is diagnosed or that have previously received systemic therapy. The goal of this project is to assist participating institutions in integrating next-generation sequencing results and building a real-time data storage and sharing platform, as well as establishing a tumor molecular biological atlas of Taiwanese patients with urothelial carcinoma and renal cell carcinoma. The data will be linked with clinical prognosis to facilitate the rapid screening of patients for effective potential therapeutic drugs and clinical trials, which is anticipated to prolong the survival rate of patients.

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

  • Ages 20 and above. (Age >= 18 years old from January 1, 2023).
  • Pathological reports showed renal cell carinoma or urothelial carcinoma.
  • muscle-invasive bladder cancer or positive of N/M grade, UTUC of T2 at least or positive of N/M grade, or stage III/IV RCC
  • Willingness to provide the residual biopsy/operative tumor samples for study.
  • Life expectancy more than 3 months.
  • Patients fully understand the protocol with the willingness to have regular follow-up.

排除标准

  • Inability to cooperate by providing a complete medical history.
  • Ineligible tumor tissue samples for next-generation sequencing of genetic testing.
  • Undesirable compliance.
  • Having a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded.

结局指标

主要结局

Development of an integrated database of genetic background

时间窗: From date of registration to 30 Sep 2029

Development of an integrated database of genetic background from populations, underlying status, clinical information, and therapeutic outcomes in carcinogen-related advanced urologic tumors.

次要结局

未报告次要终点

研究者

发起方
National Health Research Institutes, Taiwan
申办方类型
Other
责任方
Sponsor

研究点 (1)

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