UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Elucidation of the mechanism that diabetes affects carcinogenesis
Title of the study (Brief title)	Elucidation of the mechanism that diabetes affects carcinogenesis
Region	Japan

Condition
Condition	diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	elucidation of the mechanism that diabetes affects carcinogenesis
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Abnormal lipid metabolism
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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	presence or absence of diabetes
Key exclusion criteria	rejection of patient
Target sample size	20

Research contact person
Name of lead principal investigator	tetsu fukunaga
Organization	juntendo university
Division name	gastroenterology and minimally invasive surgery
Address	2-1-1 hongo bunkyo tokyo
TEL	03-3813-3111
Email	egawa@juntendo.ac.jp

Public contact
Name of contact person	hiroki egawa
Organization	juntendo university
Division name	gastroenterology and minimally invasive surgery
Address	2-1-1 hongo bunkyo tokyo
TEL	03-3813-3111
Homepage URL
Email	egawa@juntendo.ac.jp

Sponsor
Institute	jyuntendo university
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	2018 Year 07 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 06 Month 30 Day
Anticipated trial start date	2018 Year 07 Month 01 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	none

Management information
Registered date	2018 Year 06 Month 29 Day
Last modified on	2018 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037860