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Clinical Trials/NCT04674501
NCT04674501
Unknown
Not Applicable

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

Yonsei University1 site in 1 country200 target enrollmentDecember 22, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients Who Receive Thoracic Irradiation
Sponsor
Yonsei University
Enrollment
200
Locations
1
Primary Endpoint
Cardiotoxicity rate
Last Updated
5 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 22, 2020
End Date
December 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Cardiotoxicity rate

Time Frame: 2 years

Secondary Outcomes

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

Study Sites (1)

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