UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000019064