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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028152
Receipt No. R000032129
Scientific Title Risk factors for diabetes induced by immune checkpoint inhibitor
Date of disclosure of the study information 2017/07/31
Last modified on 2019/01/16

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Basic information
Public title Risk factors for diabetes induced by immune checkpoint inhibitor
Acronym Study on diabetes induced immune checkpoint inhibitor
Scientific Title Risk factors for diabetes induced by immune checkpoint inhibitor
Scientific Title:Acronym Study on diabetes induced immune checkpoint inhibitor
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Study of clinical presentation and risk factor of diabetes induced by immune checkpoint inhibitor.
Basic objectives2 Others
Basic objectives -Others biological changes
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Chages in glucose tolerance test
Key secondary outcomes Blood glucose, HbA1c, glycoalbmin, serum C-peptide, thyroid hormone, TSH, HLA genotype

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 75g oral glucose tolerance test
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 Patients administrated immune checkpoint inhibitor.
Patients aged over 20 who agree with this research.
Key exclusion criteria 1)Patients judged inappropriate to 75g oral glucose tolerance test.
2)Patients who are pregnant, hope to be pregnant, or are in lactation period.
3)Patients judged inappropriate to participate in this research by doctors.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasumichi mori MD, PhD,
Organization Toranomon Hospital.
Division name Department of Endocrinology and Metabolism.
Zip code
Address 2-2-2 Toranomon Minato ward, Tokyo, 105-8470, Japan
TEL 03-3588-1111
Email ymori-metab@toranomon.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasumichi mori
Organization Toranomon Hospital.
Division name Department of Endocrinology and Metabolism.
Zip code
Address 2-2-2 Toranomon Minato ward, Tokyo, 105-8470, Japan
TEL 03-3588-1111
Homepage URL
Email ymori-metab@toranomon.gr.jp

Sponsor
Institute Toranomon Hospital Department of Endocrinology and Metabolism.
Institute
Department

Funding Source
Organization Toranomon Hospital.
Department of Endocrinology and Metabolism.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 31 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
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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 10 Day
Last modified on
2019 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032129

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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