UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024709 |
|---|---|
| Receipt number | R000028427 |
| Scientific Title | Nationwide registration and clinical evaluation of the heavy particle beam therapy studies. |
| Date of disclosure of the study information | 2016/11/04 |
| Last modified on | 2024/01/10 13:00:35 |
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Basic information
Public title
Nationwide registration and clinical evaluation of the heavy particle beam therapy studies.
Acronym
Nationwide registration and clinical evaluation of the heavy particle beam therapy studies.
Scientific Title
Nationwide registration and clinical evaluation of the heavy particle beam therapy studies.
Scientific Title:Acronym
Nationwide registration and clinical evaluation of the heavy particle beam therapy studies.
Region
| Japan |
Condition
Condition
Head and Neck
Lung
Esophagus
Lower gastrointestinal tract
Hepato-biliary-pancreatic
Urinary organ
mammary-uterine-cervix
Bone and Soft tissue
Metastatic disease
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1. Construction of the Database for heavy particle beam therapy studies.
2. Evaluation of the safety and efficacy of heavy particle radiation therapy for each disease, and conduction of the data analysis and so on that will contribute to the reporting of heavy particle radiation therapy insurance over the long term.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
survival rate
Key secondary outcomes
Local control period
Progression-free survival
Adverse event
Evaluation of Quality of Life
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
All cases receiving heavy particle radiation therapy in each collaborative research institute will be covered from 1 May 2016 to 31 March 2026.
Key exclusion criteria
If patients or their families refuse to provide materials for this research, they are excluded.
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | HITOSHI |
| Middle name | |
| Last name | ISHIKAWA |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
TEL
043-206-3300
ishikawa.hitoshi@qst.go.jp
Public contact
Name of contact person
| 1st name | HISATERU |
| Middle name | |
| Last name | OHBA |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
TEL
043-206-4185
Homepage URL
ohba.hisateru@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
MEXT (Japan)
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
Certified Review Board, National Institutes for Quantum and Radiological Science and Technology
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
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
量子科学技術研究開発機構QST病院（千葉県）、兵庫県立粒子線医療センター（兵庫県）、群馬大学医学部附属病院（群馬県）、神奈川県立がんセンター（神奈川県）、九州国際重粒子線がん治療センター（佐賀県）、大阪重粒子線センター（大阪府）、山形大学医学部附属病院（山形県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 04 | 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
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. This study is a forward vision observation study, and there is no invasion / intervention of the subject by this research.
2. The subjects will be all cases receiving heavy particle radiation therapy at each collaborative research institution from May 1, 2016 to March 31, 2026.
3. We will disclose information at each facility and target cases that did not refuse to provide materials.
Management information
Registered date
| 2016 | Year | 11 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028427
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
