UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028991 |
|---|---|
| Receipt number | 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 | 2023/09/08 10:36:52 |
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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
250
Research contact person
Name of lead principal investigator
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Masuda |
Organization
Kobe Graduate School of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine,
Zip code
650-0017
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6305
atmasuda@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Inomata |
Organization
Kobe Graduate School of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6305
Homepage URL
inomat@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Department of Internal Medicine, Kobe Graduate School of Medicine
Institute
Department
Personal name
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
CTRC, Kobe Univ
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel
078-382-5652
rinri@med.kobe-u.ac.jp
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
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
| 2023 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033173
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
