UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049580 |
|---|---|
| Receipt number | R000056467 |
| Scientific Title | Changes in intracellular metabolism of pancreatic neuroendocrine tumors |
| Date of disclosure of the study information | 2022/11/21 |
| Last modified on | 2022/11/21 23:52:44 |
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Basic information
Public title
Changes in intracellular metabolism of pancreatic neuroendocrine tumors
Acronym
Changes in intracellular metabolism of pancreatic neuroendocrine tumors
Scientific Title
Changes in intracellular metabolism of pancreatic neuroendocrine tumors
Scientific Title:Acronym
Changes in intracellular metabolism of pancreatic neuroendocrine tumors
Region
| Japan |
Condition
Condition
Pancreatic neuroendocrine tumors
Classification by specialty
| Gastroenterology | Endocrinology and Metabolism | Hematology and clinical oncology |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether expression of PFKFB3 in pancreatic neuroendocrine tumors are increased using resected pancreatic specimens.
Basic objectives2
Others
Basic objectives -Others
To evaluate whether expression of PFKFB3 in islets accompanied by pancreatic neuroendocrine tumors are increased or not.
To investigate factors which contribute to the upregulation of PFKFB3 expression by examining the relationship between PFKFB3-positive pancreatic beta cell ratio and expression intensity and clinical parameters.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) The extent of PFKFB3 expression in pancreatic neuroendocrine tumors
2) PFKFB3-positive beta cell ratio in the islets accompanied by pancreatic neuroendocrine tumors
Key secondary outcomes
1) Comparison of PFKFB3-positive beta cell ratio in the islets between non-diabetics and patients with diabetes
2) Relationship between PFKFB3 positive ratio and cell proliferation in pancreatic neuroendocrine tumors
3) Relationship between PFKFB3 positive ratio in pancreatic neuroendocrine tumors and patients' background characteristics
4) Relationship between PFKFB3 positive beta cell ratio in islets and patients' background characteristics
Base
Study type
Others,meta-analysis etc
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
Agreement to participate to this study
Key exclusion criteria
Participants who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nomoto |
Organization
Hokkaido University Hospital
Division name
Department of diabetology and endocrinology
Zip code
060-8648
Address
North 15 West 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
hnomoto@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nomoto |
Organization
Hokkaido University Hospital
Division name
Department of diabetology and endocrinology
Zip code
060-8638
Address
N-15, W-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
0117065915
Homepage URL
hnomoto@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
N14, W5, Kita-ku, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2022 | Year | 11 | Month | 21 | 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
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the expression of PFKFB3 in pancreatic neuroendocrine tumors and attached pancreatic islets. The relationship between PFKFB3 expression and patients' characteristics will also be assessed.
Management information
Registered date
| 2022 | Year | 11 | Month | 21 | Day |
Last modified on
| 2022 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056467
