UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062019 |
|---|---|
| Receipt number | R000070967 |
| Scientific Title | Study on setup for carbon-ion radiotherapy in breast cancer |
| Date of disclosure of the study information | 2026/06/23 |
| Last modified on | 2026/06/23 09:53:39 |
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Basic information
Public title
Retrospective observational study on patient setup in carbon-ion radiotherapy for breast cancer
Acronym
Retrospective observational study on patient setup in carbon-ion radiotherapy for breast cancer
Scientific Title
Study on setup for carbon-ion radiotherapy in breast cancer
Scientific Title:Acronym
Retrospective observational study on patient setup in carbon-ion radiotherapy for breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate setup time as well as marker positional deviations and trends in breast cancer patients undergoing carbon-ion radiotherapy, based on patient anatomical characteristics, background factors, pre-treatment procedures, and irradiation positions, in order to determine optimal treatment positioning and margin settings.
Basic objectives2
Others
Basic objectives -Others
Improvement of positional accuracy and reduction of treatment preparation time in carbon-ion radiotherapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of total setup time between the supine and prone positions.
Key secondary outcomes
Marker positional deviations and trends in the supine and prone positions, and subdivided time for each step (immobilization device setup, X-ray imaging, and repositioning).
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
Breast cancer patients who underwent carbon-ion radiotherapy with metallic marker implantation between June 2017 and February 2024.
Key exclusion criteria
Patients for whom setup time or marker positional data were not recorded
Patients who declined the use of their information for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Wakatsuki |
Organization
National Institutes for Quantum Science and Technology (QST)
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3360
wakatsuki.masaru@qst.go.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Wakatsuki |
Organization
National Institutes for Quantum Science and Technology (QST)
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3360
Homepage URL
wakatsuki.masaru@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology (QST)
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science and Technology (QST)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology (QST)
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
国立研究開発法人量子科学技術研究開発機構(QST) QST病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 23 | 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
| 2026 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is being conducted as a retrospective observational study.
Management information
Registered date
| 2026 | Year | 06 | Month | 23 | Day |
Last modified on
| 2026 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070967
