UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046354 |
|---|---|
| Receipt number | R000052892 |
| Scientific Title | A retrospective study of cardiac event occurrence in thoracic carbon-ion radiotherapy |
| Date of disclosure of the study information | 2021/12/13 |
| Last modified on | 2021/12/11 14:39:58 |
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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
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
wakatsuki.masaru@qst.go.jp
Sponsor or person
Institute
National Institute for Quantum and Radiological Science and Technology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052892
