UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018184
Receipt number R000021056
Scientific Title mTOR activation in brain and spinal tumors
Date of disclosure of the study information 2015/07/06
Last modified on 2020/01/05 17:02:54

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Basic information

Public title

mTOR activation in brain and spinal tumors

Acronym

mTOR activation in brain and spinal tumors

Scientific Title

mTOR activation in brain and spinal tumors

Scientific Title:Acronym

mTOR activation in brain and spinal tumors

Region

Japan


Condition

Condition

Brain and spinal tumors

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of activation of the mTOR signaling pathway in brain and spinal tumors

Basic objectives2

Others

Basic objectives -Others

Evaluation of activation of the mTOR signaling pathway in brain or spinal tumors which were already removed and fixed in paraffin blocks.

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Activation of mTOR in each kind of tumors

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

Samples that were diagnosed as brain or spinal tumors

Key exclusion criteria

when patients refused to participate this study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kazuhiko
Middle name
Last name Nozaki

Organization

Shiga University of Medical Science

Division name

Neurosurgery

Zip code

520-2192

Address

Setatsukinowacho, Otsu, Shiga, Japan

TEL

0775482257

Email

noz@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name Naoki
Middle name
Last name Nitta

Organization

Shiga University of Medical Science

Division name

Neurosurgery

Zip code

520-2192

Address

Setatsukinowa-cho, Otsu, Shiga

TEL

0775482257

Homepage URL


Email

nnitta@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Department of Neurosurgery, Shiga University of Medical Science

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shiga University of Medical Science Research Ethics Committee

Address

Seta Tsukinowa-cho, Otsu, Shiga, JAPAN

Tel

077-548-3576

Email

hqrec@belle.shiga-med.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

滋賀医科大学医学部脳神経外科


Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 06 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

24

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

Completed

Date of protocol fixation

2015 Year 07 Month 06 Day

Date of IRB

2015 Year 06 Month 23 Day

Anticipated trial start date

2015 Year 07 Month 06 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is a retrospective study in which we use the samples that we already removed.


Management information

Registered date

2015 Year 07 Month 03 Day

Last modified on

2020 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021056


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name