- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04674501
Radiotherapy for Thoracic and Breast Cancer and the Related Cardiotoxicity Following Treatment (RACCOON)
A Prospective Cohort Study of Patients Receiving Radiotherapy for Thoracic and Breast Cancer and the Related Cardiotoxicity Following Treatment (RACCOON)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Hong In Yoon
- Phone Number: 82-2-2228-8110
- Email: yhi0225@yuhs.ac
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System
-
Contact:
- Hong In Yoon
- Phone Number: 82-2-2228-8110
- Email: yhi0225@yuhs.ac
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiotoxicity rate
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 2 years
|
2 years
|
Progression-free survival
Time Frame: 2 years
|
2 years
|
Cancer-specific survival
Time Frame: 2 years
|
2 years
|
Other toxicity rates
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hong In Yoon, Severance Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2020-1093
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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