Radiotherapy for Thoracic and Breast Cancer and the Related Cardiotoxicity Following Treatment (RACCOON)

NCT ID: NCT04674501

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-22

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Patients Who Receive Thoracic Irradiation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Thoracic irradiation

A cohort of cancer patients who receive thoracic irradiation. Patients with any type of malignancy, such as lung cancer, breast cancer, esophageal cancer, or thymoma, are eligible as long as the patients undergo thoracic irradiation.

Cardiac evaluation and blood sampling

Intervention Type PROCEDURE

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.

The patients who developed cardiotoxicity will undergo blood sampling to establish cardiomyocytes derived from induced pluripotent stem cells, which will be used for identifying the mechanisms of radiation-induced cardiotoxicity and therapeutic targets.

Interventions

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Cardiac evaluation and blood sampling

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.

The patients who developed cardiotoxicity will undergo blood sampling to establish cardiomyocytes derived from induced pluripotent stem cells, which will be used for identifying the mechanisms of radiation-induced cardiotoxicity and therapeutic targets.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients with a history of previous thoracic irradiation
2. Patients who refused consent
3. Patients with a history of heart failure before radiotherapy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hong In Yoon

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hong In Yoon

Role: CONTACT

Phone: 82-2-2228-8110

Email: [email protected]

Facility Contacts

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Hong In Yoon

Role: primary

Other Identifiers

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4-2020-1093

Identifier Type: -

Identifier Source: org_study_id