UMIN-CTR Clinical Trial

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