UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062757 |
|---|---|
| Receipt number | R000071219 |
| Scientific Title | Morphological and Biochemical Characterization of Novel Peptides Produced in Human Pancreatic Islets |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/31 21:12:22 |
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Basic information
Public title
Morphological and Biochemical Characterization of Novel Peptides Produced in Human Pancreatic Islets
Acronym
Morphological and Biochemical Characterization of Novel Peptides Produced in Human Pancreatic Islets
Scientific Title
Morphological and Biochemical Characterization of Novel Peptides Produced in Human Pancreatic Islets
Scientific Title:Acronym
Morphological and Biochemical Characterization of Novel Peptides Produced in Human Pancreatic Islets
Region
| Japan |
Condition
Condition
Patients with pancreatic or biliary diseases undergoing pancreatectomy
Classification by specialty
| Endocrinology and Metabolism | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identification of the Producing Cells, Molecular Forms, and Biological Functions of Novel Peptides in Human Pancreatic Islets
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of the Producing Cells, Molecular Forms, and Biological Functions of Novel Peptides in Human Pancreatic Islets
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with pancreatic or bile duct diseases undergoing pancreatectomy
Key exclusion criteria
Patients receiving systemic corticosteroid therapy
Patients with diabetes mellitus
Patients who have received preoperative chemotherapy
Patients with active hepatitis
Patients with dyspnea requiring supplemental oxygen due to interstitial pneumonia, pulmonary fibrosis, or other respiratory disorders
Patients undergoing dialysis for chronic renal failure
Patients with inflammatory bowel disease
Patients with an active infection, excluding cholangitis
Patients with psychiatric disorders or psychiatric symptoms that are considered to make participation in the study difficult
Patients deemed unsuitable for participation in the study by the principal investigator for any other reason
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Seiko |
| Middle name | |
| Last name | Hirono |
Organization
Hyogo medical university
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo
TEL
0798-45-6582
se-hirono@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Kitahata |
Organization
Hyogo Medical University
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo
TEL
0798-45-6582
Homepage URL
yu-kitahata@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Hyogo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University
Address
1-1 Mukogawa, Nishinomiya, Hyogo
Tel
0798-45-6111
rinri@hyo-med.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
| 2026 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 08 | Month | 31 | Day |
Last modified on
| 2026 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071219
