UMIN-CTR Clinical Trial

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
Email	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
Email	hnomoto@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056467