UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022917
Receipt number R000026411
Scientific Title Observational study of proton therapy patients treated with advanced medical care unified treatment policy, National case registration
Date of disclosure of the study information 2016/07/01
Last modified on 2022/08/03 08:15:00

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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 or person

Institute

Hokkaido University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026411


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name