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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028991
Receipt No. R000033173
Scientific Title The relationship between BMI change and diagnosis of pancreatic cancer in patients with diabetes worsening
Date of disclosure of the study information 2017/11/01
Last modified on 2017/09/04

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Basic information
Public title The relationship between BMI change and diagnosis of pancreatic cancer in patients with diabetes worsening
Acronym Diagnostic strategy of pancreatic cancer in DM worsening
Scientific Title The relationship between BMI change and diagnosis of pancreatic cancer in patients with diabetes worsening
Scientific Title:Acronym Diagnostic strategy of pancreatic cancer in DM worsening
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship between BMI change and diagnosis of pancreatic cancer in patients with diabetes worsening
Basic objectives2 Others
Basic objectives -Others To compare the diagnostic rate of gastric cancer or colon cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate the diagnosis rate of pancreatic cancer according to the degree of BMI change
Key secondary outcomes To compare the diagnostic rate of gastric cancer or colon cancer

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 (1) age: more than 20 years old
(2) type 2 diabetes patients
(3) elevation of HbA1c (more than 0.5%) without drug change
(4) agree to participate this study
Key exclusion criteria (1) steroid use
(2) diseases which are likely to elevate blood glucose

Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuhiro Masuda
Organization Kobe Graduate School of Medicine
Division name Division of Gastroenterology, Department of Internal Medicine,
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-6305
Email atmasuda@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuhiro Masuda
Organization Kobe Graduate School of Medicine
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-6305
Homepage URL
Email atmasuda@med.kobe-u.ac.jp

Sponsor
Institute Division of Gastroenterology, Department of Internal Medicine, Kobe Graduate School of Medicine
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)

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 11 Month 01 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 09 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information physical exam: height, weight, BMI
blood exam: blood glucose, HbA1c, GA, IRI, CPR, serum CEA, CA19-9, SPAN-1, DUPAN-2
imaging studies: CT, MRI, EUS, GFS, CS
medical exam by interview: past history, family history, social history, BMI change
pathological characteristics of pancreatic cancer (stage, size, metastasis etc.)
treatment of pancreatic cancer (surgery, chemotherapy)

Management information
Registered date
2017 Year 09 Month 04 Day
Last modified on
2017 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033173

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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