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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016415
Receipt No. 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

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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
Institute Shiga University of Medical Science
Institute
Department

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
URL(English) https://upload.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


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