UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038486
Receipt number R000043856
Scientific Title Study on treatment method, age group, complications, and outcome of meningiomas and hemangioblastomas using DPC
Date of disclosure of the study information 2019/11/04
Last modified on 2023/11/06 09:02:23

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Basic information

Public title

Study on treatment method, age group, complications, and outcome of meningiomas and hemangioblastomas using DPC

Acronym

Study on treatment method, age group, complications, and outcome of meningiomas and hemangioblastomas using DPC

Scientific Title

Study on treatment method, age group, complications, and outcome of meningiomas and hemangioblastomas using DPC

Scientific Title:Acronym

Study on treatment method, age group, complications, and outcome of meningiomas and hemangioblastomas using DPC

Region

Japan


Condition

Condition

Meningioma, Hemangioblastoma

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Conduct research on meningiomas, hemangioblastoma treatments, age groups, complications, and outcomes.

Basic objectives2

Others

Basic objectives -Others

Risk factors for Barthel Index (BI) changes, mortality,complications

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Barthel Index(BI)

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

1 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Surgical cases

Key exclusion criteria

Non-surgical cases

Target sample size

10000


Research contact person

Name of lead principal investigator

1st name FUSAO
Middle name
Last name IKAWA

Organization

Graduate School of Biomedical and Health Sciences, Hiroshima University

Division name

Department of Neurosurgery

Zip code

734-8551

Address

1-2-3 Kasumi, Minami-ku, Hiroshima, Japan

TEL

082-257-5226

Email

fikawa-nsu@umin.ac.jp


Public contact

Name of contact person

1st name FUSAO
Middle name IKAWA
Last name IKAWA

Organization

Graduate School of Biomedical and Health Sciences, Hiroshima University

Division name

Department of Neurosurgery

Zip code

693-8555

Address

1-2-3 Kasumi, Minami-ku, Hiroshima, Japan

TEL

082-257-5226

Homepage URL


Email

fikawa-nsu@umin.ac.jp


Sponsor or person

Institute

Graduate School of Biomedical and Health Sciences, Hiroshima University
Department of Neurosurgery

Institute

Department

Personal name



Funding Source

Organization

the Japan Society for the Promotion of Science, Grant-in-Aid for Scientific Research (C) 17K10829

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Graduate School of Biomedical and Health Sciences Hiroshima University

Address

1-2-3 Kasumi, Minami-ku, Hiroshima, Japan

Tel

082-257-5907

Email

kasumi-kenkyu@office.hiroshima-u.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

2019 Year 11 Month 04 Day


Related information

URL releasing protocol

partially published in this study

Publication of results

Unpublished


Result

URL related to results and publications

partially published in this study

Number of participants that the trial has enrolled

10000

Results

End of follow-up

Results date posted

2022 Year 05 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 08 Month 01 Day

Baseline Characteristics

End of follow-up

Participant flow

End of follow-up

Adverse events

End of follow-up

Outcome measures

End of follow-up

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2018 Year 12 Month 19 Day

Date of IRB

2018 Year 12 Month 19 Day

Anticipated trial start date

2018 Year 12 Month 19 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry

2020 Year 12 Month 31 Day

Date trial data considered complete

2021 Year 12 Month 31 Day

Date analysis concluded

2023 Year 10 Month 31 Day


Other

Other related information

Risk factor for deteriorarion of BI, in-hospital mortality, and complication


Management information

Registered date

2019 Year 11 Month 03 Day

Last modified on

2023 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043856


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name