UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028152 |
|---|---|
| Receipt number | 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 19:41:56 |
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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
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
ymori-metab@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital Department of Endocrinology and Metabolism.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032129
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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