跳至主要内容
临床试验/NCT05793281
NCT05793281已完成不适用

A Retrospective Observational Study to Investigate the Prevalence of NTRK Gene Fusion Positive in Solid Tumor in Japan

Bayer1 个研究点 分布在 1 个国家目标入组 46,621 人开始时间: 2023年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Bayer
入组人数
46,621
试验地点
1
主要终点
Distribution of cancer types in patients with NTRK fusion positive among all, adult and pediatric

研究概览

简要总结

This is an observational study in which data from the past of people with solid tumors harboring an NTRK gene fusion in Japan are studied. In observational studies, only observations are made without specified advice or interventions.

Advanced or recurrent solid tumor harboring an NTRK gene fusion is a rare type of solid cancer caused by specific changes in the genes called NTRK gene fusion, and which has spread to nearby tissues and/or lymph nodes or has returned. Due to this change in the gene, an altered protein known as a TRK fusion protein is made, which can cause cancer cells to grow and survive.

The main purpose of this study is to learn more about NTRK gene fusion in people in Japan. To do this, researchers will collect information on the number or percentage of Japanese people with NTRK gene fusion in any solid tumor.

The data will come from the national database called C-CAT. They will cover the period from June 2019 until January 2023.

Besides this data collection, no further tests or examinations are planned, and no visits are required in this study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with any solid tumor and genome profiling results

排除标准

  • 未提供

结局指标

主要结局

Distribution of cancer types in patients with NTRK fusion positive among all, adult and pediatric

时间窗: Retrospective data analysis from June 2019 to the latest data available (planned end of February 2023)

Prevalence of patients with NTRK gene fusions by patient characteristic categories, such as tumor types

时间窗: Retrospective data analysis from June 2019 to the latest data available (planned end of February 2023)

次要结局

未报告次要终点

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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