UMIN-CTR Clinical Trial

Basic information
Public title	OMICS analysis of glioma
Acronym	OMICS analysis of glioma
Scientific Title	OMICS analysis of glioma
Scientific Title:Acronym	OMICS analysis of glioma
Region	Japan

Condition
Condition	glioma
Classification by specialty	Neurosurgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	OMIC analysis consists of examinations with Genome,Transcriptome, Proteome, Metabolome, Phenome. By using OMICS analysis of patients with glioma, we will reveal mechanism of disease progression, treatment sensivity.
Basic objectives2	Others
Basic objectives -Others	Genomic information
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Genome,Transcriptome, Proteome, Metabolome
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	patients with glioma
Key exclusion criteria	no agreement
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Fumihiko Middle name Last name Matsuda
Organization	Kyoto University Graduate School of Medicine
Division name	Center for Genomic Medicine
Zip code	6068507
Address	Shogoinkawahara-cho 53 Kyotoshisakyo-ku, Kyoto-hu, Japan
TEL	075-751-4157
Email	fumi@genome.med.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Yoshiki Middle name Last name Arakawa
Organization	Kyoto University Graduate School of Medicine
Division name	Deaprtment of Neurosurgery
Zip code	6068507
Address	Kawahara-cho Shogoin Sakyo-ku, Kyoto
TEL	075-751-3459
Homepage URL	https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000011955
Email	yarakawa@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine Center for Genomic Medicine
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-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	京都大学医学研究科（京都府）

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 03 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	40
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	No longer recruiting
Date of protocol fixation	2013 Year 08 Month 28 Day
Date of IRB	2013 Year 08 Month 28 Day
Anticipated trial start date	2013 Year 10 Month 03 Day
Last follow-up date	2023 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	OMICS analysis

Management information
Registered date	2013 Year 10 Month 03 Day
Last modified on	2022 Year 10 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013966