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
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
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
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
