UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Risk of pancreatic cancer in patients with diabetes mellitus: a Prospective Cohort Study.
Title of the study (Brief title)	Risk of pancreatic cancer in patients with diabetes mellitus: a Prospective Cohort Study.
Region	Japan

Condition
Condition	Diabetes mellitus
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the risk of pancreatic cancer in patients with new onset and recent worsening of diabetes mellitus.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The incidence rate of pancreatic cancer.
Key secondary outcomes	Laboratory data, clinical features, the risk of cancer of other organs, and mortality.

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	Patiens with new onset of diabetes mellitus within recent 2 years. Patients with recent exacerbation of diabetes mellitus.
Key exclusion criteria	Patients who have reasons not to perform MRI such as attachment of pacemakers.
Target sample size	300

Research contact person
Name of lead principal investigator	Akira Kurita
Organization	Kitano Hospital
Division name	Division of Gastroenterology and Hepatology
Address	2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan
TEL	06-6312-8831
Email	a-kurita@kitano-hp.or.jp

Public contact
Name of contact person	Akira Kurita
Organization	Kitano Hospital
Division name	Division of Gastroenterology and Hepatology
Address	2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan
TEL	06-6312-8831
Homepage URL
Email	a-kurita@kitano-hp.or.jp

Sponsor
Institute	Kitano Hospital
Institute
Department

Funding Source
Organization	Kitano Hospital
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	北野病院

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 12 Month 20 Day
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry	2023 Year 04 Month 30 Day
Date trial data considered complete	2023 Year 05 Month 31 Day
Date analysis concluded	2023 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	cohort study

Management information
Registered date	2015 Year 02 Month 23 Day
Last modified on	2016 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018686