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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029521
Receipt No. R000033585
Scientific Title Association of MRI features with IDH mutation status in patients with glioblastoma.
Date of disclosure of the study information 2017/10/17
Last modified on 2019/04/15

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Basic information
Public title Association of MRI features with IDH mutation status in patients with glioblastoma.
Acronym MRI for IDH mutation in glioblastoma
Scientific Title Association of MRI features with IDH mutation status in patients with glioblastoma.
Scientific Title:Acronym MRI for IDH mutation in glioblastoma
Region
Japan

Condition
Condition glioblastoma
Classification by specialty
Neurology Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To identihy MRI findings and their combinations associated with IDH mutant status in glioblastoma.
Basic objectives2 Others
Basic objectives -Others diagnostic efficacy
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes tumor size, enhancement, non-enhanced region, necrosis size, edema size, location, ADC, rCBV.
Key secondary outcomes subgroup analysis stratified by age, gender, etc.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Glioblastoma confirmed by postoperative pathological exanination.
2. Preoperative MRI for glioblastoma.
- T1WI
- contrasted T1WI
- transverse T2WI
- FLAIR
- DWI
- DSC MR perfusion (if available)
3. IDH mutation tests of surgical specimen.
4. Twenty years or older at the time of preoperative MRI.
Key exclusion criteria 1. Medication which affects MRI e.g. steroids.
2. Tissue type other than glioblastoma e.g. giant cell glioblastoma, gliosarcoma, epithelioid glioblastoma.
3. No transverse T2WI.
4. Not evaluable for artifacts.
5. Recurrence after treatment.
6. Judged ineligible by investigators.
Target sample size 450

Research contact person
Name of lead principal investigator
1st name Toshinori
Middle name
Last name Hirai
Organization University of Miyazaki
Division name Department of Radiology, Faculty of Medicine
Zip code 8891692
Address 5200 Kiyotakecho Kihara, Miyazaki-city, Miyazaki, 889-1692
TEL 0985-85-2807
Email toshinorh@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name Toshinori
Middle name
Last name Hirai
Organization University of Miyazaki
Division name Department of Radiology, Faculty of Medicine
Zip code 8891692
Address 5200 Kiyotakecho Kihara, Miyazaki-city, Miyazaki, 889-1692
TEL 0985-85-2807
Homepage URL
Email toshinorh@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization ethics committee at university of Miyazaki
Address 5200 Kiyotakecho Kihara, Miyazaki-city, Miyazaki, 889-1692
Tel 0985-85-9010
Email igakubu_kenkyu@med.miyazaki-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 宮崎大学(宮崎県)、北海道大学(北海道)、山形大学(山形県)、福島県立医科大学(福島県)、東京医科歯科大学(東京都)、順天堂大学(東京都)、山梨大学(山梨県)、埼玉県立がんセンター(埼玉県)、東京慈恵医科大学付属柏病院(千葉県)、亀田総合病院(千葉県)、筑波大学(茨城県)、横浜市立大学附属病院(神奈川県)、群馬大学(群馬県)、新潟大学(新潟県)、京都大学(京都府)、大阪大学(大阪府)、兵庫医科大学(兵庫県)、奈良県立医科大学(奈良県)、鳥取大学(鳥取県)、徳島大学(徳島県)、産業医科大学(福岡県)、長崎大学(長崎県)、熊本大学(熊本県)、大分大学(大分県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 17 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 347
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
2017 Year 06 Month 02 Day
Date of IRB
2017 Year 10 Month 10 Day
Anticipated trial start date
2017 Year 10 Month 17 Day
Last follow-up date
2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information data collection period

Management information
Registered date
2017 Year 10 Month 12 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033585

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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