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临床试验/NCT04674501
NCT04674501Unknown不适用

A Prospective Cohort Study of Patients Receiving Radiotherapy for Thoracic and Breast Cancer and the Related Cardiotoxicity Following Treatment (RACCOON)

Yonsei University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年12月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Cardiotoxicity rate

研究概览

简要总结

The purpose of this study is to investigate the risk factors and mechanisms of cardiotoxicity following thoracic radiotherapy and to provide insights in preventing radiation-related cardiotoxicity.

-Condition or disease : Thoracic irradiation -Intervention/treatment : Cardiac evaluation, Blood sampling

详细描述

Cancer patients who undergo thoracic irradiation receive a certain amount of dose to the heart. Cardiotoxicity may occur in some patients several years after radiotherapy due to the late effect of radiation. Considering that cardiotoxicity is often lethal, screening and preventing radiation-induced cardiotoxicity is crucial in patients receiving thoracic irradiation.

Patients in this cohort will undergo cardiac evaluation before and after thoracic irradiation. The dose-volume parameters for each cardiac substructures will be estimated using artificial intelligence-based auto-segmentation of the heart in CT images. Dose-volume parameters that predict cardiotoxicity will be analyzed. Among the patients who developed cardiotoxicity, blood sampling will be performed to establish cardiomyocytes derived from induced pluripotent stem cells, which will be used for identifying the mechanisms of radiation-induced cardiotoxicity and therapeutic targets.

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 with solid cancer who are subject to thoracic irradiation.
  • Patients who are 20 years old or older
  • Eastern Cooperative Oncology Group Performance Status Scale 0-2
  • Patients with cognitive abilities to receive virtual reality information

排除标准

  • Patients with a history of previous thoracic irradiation
  • Patients who refused consent
  • Patients with a history of heart failure before radiotherapy

结局指标

主要结局

Cardiotoxicity rate

时间窗: 2 years

次要结局

  • Overall survival(2 years)
  • Progression-free survival(2 years)
  • Cancer-specific survival(2 years)
  • Other toxicity rates(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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