UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Risk factors for diabetes induced by immune checkpoint inhibitor
Title of the study (Brief title)	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	Yasumichi mori MD, PhD,
Organization	Toranomon Hospital.
Division name	Department of Endocrinology and Metabolism.
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	Yasumichi mori
Organization	Toranomon Hospital.
Division name	Department of Endocrinology and Metabolism.
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000032129