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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041682
Receipt No. R000047330
Scientific Title Residues of insulin secretion differ at the different site of pancreatic cancer in spite of diabetes history
Date of disclosure of the study information 2021/03/31
Last modified on 2020/09/04

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Basic information
Public title Residues of insulin secretion differ at the different site of pancreatic cancer in spite of diabetes history
Acronym Residues of insulin secretion differ at the different site of pancreatic cancer in spite of diabetes history
Scientific Title Residues of insulin secretion differ at the different site of pancreatic cancer in spite of diabetes history
Scientific Title:Acronym Residues of insulin secretion differ at the different site of pancreatic cancer in spite of diabetes history
Region
Japan

Condition
Condition diabetes, pancreatic cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A retrospective study of diabetic pancreatic cancer patients
Basic objectives2 Others
Basic objectives -Others we examined the clinical background of pancreatic cancer patients with diabetes mellitus retrospectively due to focusing whether diabetes becomes as an ordinal factor for early detection or progression of pancreatic cancer
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes the levels of serum or urinary C-peptide immunoreactivity (CPR)
Key secondary outcomes Age, sex, height, BMI, family history of diabetes mellitus, history of smoking alcohol, family history of malignant disease, duration of diabetes, HbA1c,weight loss and period, treatment (oral hypoglycemic agent or insulin treatment or both), tumor marker (CA19-9), tumor diameter, pancreatic cancer development site and cancer treatment

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
55 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Diabetic patients with pancreatic cancer
Key exclusion criteria Patients who refused or could not be followed for pancreatic cancer
Target sample size 52

Research contact person
Name of lead principal investigator
1st name Hirotaka
Middle name
Last name Shichijo
Organization Kyorin University School of Medicine
Division name Department of Diabetes, Endocrinology and Metabolism
Zip code 1818611
Address Tokyo, Japan
TEL 0422475511
Email hirotaka.shichijo0210@gmail.com

Public contact
Name of contact person
1st name Hirotaka
Middle name
Last name Shichijo
Organization Kyorin University School of Medicine
Division name Department of Diabetes, Endocrinology and Metabolism
Zip code 1818611
Address Tokyo, Japan
TEL 0422475511
Homepage URL
Email hirotaka.shichijo0210@gmail.com

Sponsor
Institute Department of Diabetes, Endocrinology and Metabolism, Kyorin University School of Medicine
Institute
Department

Funding Source
Organization Department of Diabetes, Endocrinology and Metabolism, Kyorin University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyorin University School of Medicine
Address Tokyo, Japan
Tel 0422475511
Email hirotaka.shichijo0210@gmail.com

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
2021 Year 03 Month 31 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 36
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 No longer recruiting
Date of protocol fixation
2020 Year 05 Month 12 Day
Date of IRB
2020 Year 05 Month 12 Day
Anticipated trial start date
2020 Year 05 Month 12 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The relationship between diabetes and cancer risk has been previously shown, and various studies have shown the relationship between diabetes and cancer risk.
Pancreatic cancer is one of the cancers whose risk is increased by diabetes, but it is difficult to detect it early, and it is often advanced at the time of diagnosis, and it is known as a cancer with a poor prognosis. Conceivable. Even in outpatient clinics, patients with type 2 diabetes are diagnosed with pancreatic cancer due to poor glycemic control, and new cases of new onset.
In diabetes, we sometimes experience cases in which it is revealed that the disease is secondary diabetes due to pancreatic cancer, and it is very important to detect pancreatic cancer as early as possible. That is, the deterioration of blood glucose level and the onset of diabetes in diabetic patients are important as early detection markers for pancreatic cancer, but clinical characteristics due to differences in the background depending on the site of pancreatic cancer and the presence or absence of presymptomatic diabetes have not been reported. ..
This time, in order to clarify whether glucose metabolism abnormality is useful as an early detection marker for pancreatic cancer, clinical characteristics of diabetic patients with pancreatic cancer (site, presence or absence of presymptomatic diabetes, insulin secretory capacity, weight change, etc.) Retrospectively investigate.

Management information
Registered date
2020 Year 09 Month 04 Day
Last modified on
2020 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=R000047330

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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