UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060481 |
|---|---|
| Receipt number | R000069113 |
| Scientific Title | Multicenter retrospective study to confirm the efficacy and safety of carbon ion radiotherapy for choroidal malignant melanoma |
| Date of disclosure of the study information | 2026/01/27 |
| Last modified on | 2026/01/27 13:18:09 |
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Basic information
Public title
Multicenter retrospective study to confirm the efficacy and safety of carbon ion radiotherapy for choroidal malignant melanoma
Acronym
Multicenter retrospective study to confirm the efficacy and safety of carbon ion radiotherapy for choroidal malignant melanoma
Scientific Title
Multicenter retrospective study to confirm the efficacy and safety of carbon ion radiotherapy for choroidal malignant melanoma
Scientific Title:Acronym
Multicenter retrospective study to confirm the efficacy and safety of carbon ion radiotherapy for choroidal malignant melanoma
Region
| Japan |
Condition
Condition
choroidal malignant melanoma
Classification by specialty
| Ophthalmology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively assess the therapeutic efficacy and safety of carbon ion radiotherapy administered to patients with choroidal malignant melanoma, using clinical data collected across multiple institutions, and to analyze factors associated with treatment outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
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
Patients who received carbon ion radiotherapy for choroidal malignant melanoma at QST Hospital from April 2001 to March 2024.
Key exclusion criteria
Cases in which the secondary use of clinical data is refused when obtaining consent for treatment or other research, and cases in which the research subject or his/her representative refuses the use of clinical data in this study.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Wakatsuki |
Organization
National Institutes for Quantum Science and Technology
Division name
Dept. of Treatment and diagnosis
Zip code
263-8555
Address
4-9-1 Anakawa, Inage-ku, Chiba City, Chiba Prefecture
TEL
0432063306
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
Division name
Dept. of Treatment and diagnosis
Zip code
263-8555
Address
4-9-1 Anakawa, Inage-ku, Chiba City, Chiba Prefecture
TEL
0432063306
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
Japanese Governmental office
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 Anakawa, Inage-ku, Chiba City, Chiba Prefecture
Tel
0432063306
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
| 2026 | Year | 01 | Month | 27 | 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
341
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Target cases will be extracted using QST Hospital's patient registration database system (AMIDAS). Clinical data listed below will be obtained from the same database system, medical records, and PACS.
For patients who visited collaborating research institutions before or after undergoing heavy ion radiotherapy at QST Hospital, clinical data from those institutions will also be collected and integrated with the data from QST Hospital for analysis.
Clinical data: medical records (age, sex, diagnosis, treatment details, clinical course, prognosis, etc.), laboratory test results (blood tests, imaging examinations such as MRI and CT), pathological information (tumor size, TNM classification, presence or absence of invasion, etc.), treatment information (details of carbon ion radiotherapy, ophthalmologic procedures performed before and after radiotherapy and their contents), adverse event information (occurrence and timing), prognostic information (date of recurrence, date of death or last follow-up), and ophthalmologic examination data (visual acuity, intraocular pressure, retinal images, ultrasonographic images, etc.).
Management information
Registered date
| 2026 | Year | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069113
