UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041682
Receipt number 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 13:52:27

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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
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