Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674501
Recruitment Status : Recruiting
First Posted : December 19, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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


Condition or disease Intervention/treatment
Patients Who Receive Thoracic Irradiation Procedure: Cardiac evaluation and 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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study of Patients Receiving Radiotherapy for Thoracic and Breast Cancer and the Related Cardiotoxicity Following Treatment (RACCOON)
Actual Study Start Date : December 22, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 Procedure: 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Cardiotoxicity rate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
  2. Cancer-specific survival [ Time Frame: 2 years ]
  3. Progression-free survival [ Time Frame: 2 years ]
  4. Other toxicity rates [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Whole blood

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with solid tumors who receive thoracic irradiation
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674501


Contacts
Layout table for location contacts
Contact: Hong In Yoon 82-2-2228-8110 yhi0225@yuhs.ac

Locations
Layout table for location information
Korea, Republic of
Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System Recruiting
Seoul, Korea, Republic of
Contact: Hong In Yoon    82-2-2228-8110    yhi0225@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Investigators
Layout table for investigator information
Principal Investigator: Hong In Yoon Severance Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04674501    
Other Study ID Numbers: 4-2020-1093
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiotoxicity
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
 Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries