UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective study of cardiac event occurrence in thoracic carbon-ion radiotherapy
Acronym	A retrospective study of cardiac event occurrence in thoracic carbon-ion radiotherapy
Scientific Title	A retrospective study of cardiac event occurrence in thoracic carbon-ion radiotherapy
Scientific Title:Acronym	A retrospective study of cardiac event occurrence in thoracic carbon-ion radiotherapy
Region	Japan

Condition
Condition	Lung cancer, liver cancer, esophageal cancer etc.
Classification by specialty	Cardiology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze the relationship between cardiac radiation dose and the risk of radiation-related cardiac injury in cancer patients (lung cancer, liver cancer, esophageal cancer, etc.) treated with heavy particle radiation therapy to the chest (upper abdomen).
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of adverse cardiac events
Key secondary outcomes	Association between cardiac radiation dose and occurrence of adverse cardiac events

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Cases of heavy particle therapy for thoracic (upper abdominal) cancer patients between April 1994 and March 2021 in QST hospital.
Key exclusion criteria	Cases in which the secondary use of clinical data is refused at the time of obtaining consent for treatment or other research, and cases in which the research subject or his/her representative refuses the use of clinical data for this research.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Masaru Middle name Last name Wakatsuki
Organization	National Institute for Quantum and Radiological Science and Technology
Division name	QST Hospital
Zip code	263-8555
Address	4-9-1 Anagawa, Inage-ku, Chiba
TEL	043-206-3306
Email	wakatsuki.masaru@qst.go.jp

Public contact
Name of contact person	1st name Masaru Middle name Last name Wakatsuki
Organization	National Institute for Quantum and Radiological Science and Technology
Division name	QST Hospital
Zip code	263-8555
Address	4-9-1 Anagawa, Inage-ku, Chiba
TEL	043-206-3306
Homepage URL
Email	wakatsuki.masaru@qst.go.jp

Sponsor
Institute	National Institute for Quantum and Radiological Science and Technology
Institute
Department

Funding Source
Organization	National Institute for Quantum and Radiological Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Institute for Quantum and Radiological Science and Technology
Address	4-9-1 Anagawa, Inage-ku, Chiba
Tel	043-206-4706
Email	helsinki@qst.go.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 12 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2021 Year 09 Month 21 Day
Date of IRB	2021 Year 10 Month 13 Day
Anticipated trial start date	2022 Year 01 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A retrospective study of cardiac event occurrence in thoracic carbon-ion radiotherapy

Management information
Registered date	2021 Year 12 Month 11 Day
Last modified on	2021 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052892