UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016415
Receipt number R000019064
Scientific Title Study of causative genes of germinomas
Date of disclosure of the study information 2015/02/02
Last modified on 2020/02/06 22:02:21

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Basic information

Public title

Study of causative genes of germinomas

Acronym

Causative genes of germinomas

Scientific Title

Study of causative genes of germinomas

Scientific Title:Acronym

Causative genes of germinomas

Region

Japan Australia


Condition

Condition

germinoma

Classification by specialty

Endocrinology and Metabolism Pediatrics Neurosurgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Identification of causative genes of germinomas

Basic objectives2

Others

Basic objectives -Others

Identification of causative genes of germinomas

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Identification of causative genes of germinomas

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

two siblings with germinomas, and other family members

Key exclusion criteria

Nothing in particular

Target sample size

2


Research contact person

Name of lead principal investigator

1st name Kazuhiko
Middle name
Last name Kazuhiko

Organization

Shiga University of Medical Science

Division name

Neurosurgery

Zip code

520-2192

Address

Setatsukinowa-cho, Otsu, 520-2192 Shiga

TEL

0775482257

Email

noz@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name Naoki
Middle name
Last name Naoki

Organization

Shiga University of Medical Science

Division name

Neurosurgery

Zip code

520-2192

Address

Setatsukinowa-cho, Otsu, 520-2192 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

Shiga University of Medical Science

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

University of Queensland

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付属病院(滋賀県)


Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 02 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

2

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

Terminated

Date of protocol fixation

2014 Year 12 Month 22 Day

Date of IRB

2015 Year 02 Month 02 Day

Anticipated trial start date

2015 Year 02 Month 16 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We will identify what genes cause germinomas through massive parallel sequencing of the genes of two siblings with germinomas. We collaborate on this study with researchers in University of Queensland.


Management information

Registered date

2015 Year 02 Month 02 Day

Last modified on

2020 Year 02 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019064


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name