UMIN-CTR Clinical Trial

Basic information
Public title	Observational study of proton therapy patients treated with advanced medical care unified treatment policy, National case registration
Acronym	Observational study of proton therapy patients treated with advanced medical care unified treatment policy, National case registration
Scientific Title	Observational study of proton therapy patients treated with advanced medical care unified treatment policy, National case registration
Scientific Title:Acronym	Observational study of proton therapy patients treated with advanced medical care unified treatment policy, National case registration
Region	Japan

Condition
Condition	Malignant diseases
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Observational study, to investigate proton therapy will indicate superiority over the existing treatment methods according to the disease. To extract the disease that more detailed intervention study is to be desirable.
Basic objectives2	Others
Basic objectives -Others	To register a proton beam therapy information after May 1, 2016. Medical institutions authorized to treat patients with health insurance which are approved to do advanced medical care performed all cases registration of JASTRO specified. To evaluate with unified observation policy for each disease.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Adverse effects occurrence rate by organ Progression-free survival

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 treated each year (July 1 to June 30) in the proton therapy facility.
Key exclusion criteria	Cases that used public insurance are excluded.
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Hidefumi Middle name Last name Aoyama
Organization	Hokkaido University Hospital
Division name	Department of Radiation Oncology
Zip code	060-8638
Address	Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL	011-706-5977
Email	h-aoyama@major.ocn.ne.jp

Public contact
Name of contact person	1st name Hidefumi Middle name Last name Aoyama
Organization	Hokkaido University Hospital
Division name	Department of Radiation Oncology
Zip code	060-8648
Address	Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL	011-706-5977
Homepage URL
Email	h-aoyama@major.ocn.ne.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Hokkaido University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address	Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel	011-706-7061
Email	crjimu@huhp.hokudai.ac.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	2016 Year 07 Month 01 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 08 Month 12 Day
Date of IRB
Anticipated trial start date	2016 Year 08 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To register a proton beam therapy information after May 1, 2016. Medical institutions authorized to treat patients with health insurance which are approved to do advanced medical care performed all cases registration of JASTRO specified. To evaluate with unified observation policy for each disease.

Management information
Registered date	2016 Year 06 Month 27 Day
Last modified on	2022 Year 08 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026411