UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024977
Receipt number R000028742
Scientific Title The identification of molecular mechanisms and a new biomarker of pancreatic cancer with glucose intolerance.
Date of disclosure of the study information 2016/11/24
Last modified on 2023/05/31 09:24:00

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Basic information

Public title

The identification of molecular mechanisms and a new biomarker of pancreatic cancer with glucose intolerance.

Acronym

The identification of molecular mechanisms and a new biomarker of pancreatic cancer with glucose intolerance.

Scientific Title

The identification of molecular mechanisms and a new biomarker of pancreatic cancer with glucose intolerance.

Scientific Title:Acronym

The identification of molecular mechanisms and a new biomarker of pancreatic cancer with glucose intolerance.

Region

Japan


Condition

Condition

Pancreatic cancer, Diabetes

Classification by specialty

Hepato-biliary-pancreatic medicine Endocrinology and Metabolism Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Patients who undergo pancreatectomy are classified into 4 groups according to glucose tolerance.
Blood and surgical specimen are obtained from each group.
The purpose is to analyse RNA expression profile and then examine molecular mechanisms by which pancreatic cancer promotes glucose intolerance.

Basic objectives2

Others

Basic objectives -Others

Identify a novel biomarker of pancreatic cancer.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Expression profile of coding and non- coding RNA obtained from pancreatic cancer patients' blood and surgical specimen.

Key secondary outcomes



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.Pancreatic cancer patients who undergo a pancreatectomy operation in our hospital.
2.Pancreatic cancer without chemotherapy and radiation therapy.

Key exclusion criteria

1.Benign pancreatic disorder
2.Type 1 diabetes
3.Chronic pancreatitis

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Jun
Middle name
Last name Wada

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Nephrology, Rheumatology, Endocrinology and Metabolism

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558 Japan

TEL

086-235-7235

Email

junwada@okayama-u.ac.jp


Public contact

Name of contact person

1st name Hiroko
Middle name
Last name Takahashi

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Nephrology, Rheumatology, Endocrinology and Metabolism

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558 Japan

TEL

086-235-7235

Homepage URL


Email

hirokotakahashi@okayama-u.ac.jp


Sponsor or person

Institute

Okayama University

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

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee

Address

2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558 Japan

Tel

086-235-6503

Email

mae6605@adm.okayama-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

2016 Year 11 Month 24 Day


Related information

URL releasing protocol

not released

Publication of results

Unpublished


Result

URL related to results and publications

not released

Number of participants that the trial has enrolled

32

Results

Specific substances were not detected.

Results date posted

2022 Year 11 Month 29 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients who had pancreatic cancer.

Participant flow

Pancreatic cancer tissues were obtained.

Adverse events

non

Outcome measures

total RNA

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 11 Month 24 Day

Date of IRB

2016 Year 10 Month 12 Day

Anticipated trial start date

2016 Year 11 Month 24 Day

Last follow-up date

2020 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

prospective observational study


Management information

Registered date

2016 Year 11 Month 24 Day

Last modified on

2023 Year 05 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028742


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name